Probe, Blood-Flow, Extravascular
FDA product code DPT · Class II (moderate risk) · 21 CFR 870.2120 · Cardiovascular
48510(k) clearances
0PMA approvals
23recalls
Manufacturers
- Moor Instruments, Ltd. 8
- Vasamedics, LLC 3
- Deltex Medical Limited 3
- Hewlett-Packard Co. 3
- Aimago SA 2
- Medtronic, Inc. 2
- Spectralmd, Inc. 2
- Toshiba Medical Systems 1
- Donald L. King M.D. 1
- Advance Medical Device, Inc. 1
- Datascope Corp. 1
- General Electric Co. 1
- Acuson Computed Sonography 1
- Sonicaid, Inc. 1
- Advanced Technology Laboratories, Inc. 1
- Electro-Diagnostic Instruments 1
- Interspec, Inc. 1
- NuMED, Inc. 1
- Rwd Life Science Co., Ltd. 1
- Bio Medicus, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233076 | Laser Speckle Imaging System (RFLSI CZW)DPT · Traditional | Rwd Life Science Co., Ltd. | 05/28/2024SE |
| K163339 | Spectralmd Deepview Wound Imaging System 2.0DPT · Traditional | Spectralmd, Inc. | 08/17/2017SE |
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser…DPT · Traditional | Moor Instruments, Ltd. | 05/12/2016SE |
| K142932 | Deltex Medical KDP72 Doppler ProbeDPT · Traditional | Deltex Medical Limited | 01/22/2015SE |
| K132730 | Bio-Probe Disposable Insert with; Balance Biosurface, Carmeda Bioactive Surface…DPT · Traditional | Medtronic, Inc. | 05/30/2014SE |
| K133903 | Bio-Probe Transducer (Adult)DPT · Traditional | Medtronic, Inc. | 04/10/2014SE |
| K132163 | Moorldls-Bi Laser Doppler Burns ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/29/2014SE |
| K124049 | Deepview Digital Video Physiological Portable Imaging SystemDPT · Traditional | Spectralmd, Inc. | 04/18/2013SE |
| K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…DPT · Traditional | Aimago SA | 02/07/2013SE |
| K122943 | MOORFLPI-2 Full-Field Laser Perfusion ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/03/2013SE |
| K121429 | Aimago Easyldi Microcirculation CameraDPT · Traditional | Aimago SA | 08/10/2012SE |
| K120884 | Pericam PsiDPT · Traditional | Perimed AB | 07/03/2012SE |
| K073593 | I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour)…DPT · Traditional | Deltex Medical Limited | 01/29/2009SE |
| K060976 | MOORLD12-B1 Laser Doppler Burns ImagerDPT · Traditional | Moor Instruments, Ltd. | 03/27/2007SE |
| K063586 | Moorflpi Full-Field Laser Perfusion ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/25/2007SE |
| K063561 | Moorldls Laser Doppler Line ScannerDPT · Traditional | Moor Instruments, Ltd. | 01/19/2007SE |
| K052989 | DP240 240 Hour Doppler ProbeDPT · Traditional | Deltex Medical | 03/08/2006SE |
| K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRDPT · Traditional | Moor Instruments, Ltd. | 12/10/2003SE |
| K013939 | Jostra Flowprobe FP-32EDPT · Traditional | Jostra AG | 12/14/2001SE |
| K012747 | Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P)DPT · Special | Medtronic Perfusion Systems | 09/14/2001SE |
| K980383 | Mooorldi Laser Doppler ImagerDPT · Traditional | Moor Instruments, Ltd. | 04/30/1998SE |
| K963703 | Accuflo Monitoring System (1800)/ Accuflo Probe (8000)DPT · Traditional | International Biophysics Corp. | 04/08/1998SE |
| K962700 | Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring…DPT · Traditional | Vasamedics, LLC | 04/09/1997SE |
| K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe KitDPT · Traditional | Vasamedics, LLC | 10/11/1996SESK |
| K951832 | Laserflo Blood Perfusion Single Use Probes Models SUP-440, SUPR-434 SUP-433DPT · Traditional | Vasamedics, LLC | 03/21/1996SE |
| K942377 | Transtar Pressure TransducerDPT · Traditional | Medex, Inc. | 08/16/1994SE |
| K924208 | Bio-Probe(R) Blood Flow Monitoring SYST(TX-50/50P)DPT · Traditional | Medtronic Bio-Medicus, Inc. | 07/08/1993SE |
| K902977 | K3 Computer SystemsDPT · Traditional | Donald L. King M.D. | 04/28/1992SE |
| K912404 | Transesophageal Transducer Thermal SafetyDPT · Traditional | Hewlett-Packard Co. | 11/07/1991SE |
| K910441 | Floscope MicrodopDPT · Traditional | Advance Medical Device, Inc. | 03/21/1991SE |
| K905728 | Sonos 500 and Sonos 1000 Ultrasound Imaging SystemDPT · Traditional | Hewlett-Packard Co. | 03/15/1991SE |
| K896437 | Kontron Sigma 44 HVCD Ultrasound Imaging SystemDPT · Traditional | Kontron Instruments, Inc. | 12/03/1990SE |
| K896435 | HP Sonos 500 and Sonos 1000 Ultra. Imaging SystemDPT · Traditional | Hewlett-Packard Co. | 02/07/1990SE |
| K881303 | Triton Model 100 Pulsed Doppler Blood FlowmeterDPT · Traditional | Triton Technology, Inc. | 11/29/1988SE |
| K874138 | Accucom 2DPT · Traditional | Datascope Corp. | 06/01/1988SE |
| K873214 | Apx Cardio Echocardiography System #H4300DPT · Traditional | General Electric Co. | 06/01/1988SE |
| K874861 | Acuson S328 Transducer for Cardiac Color Flow App.DPT · Traditional | Acuson Computed Sonography | 05/11/1988SE |
| K875266 | SSH-160A Ultrasonic Pulsed Echo Imaging SystemDPT · Traditional | Toshiba Medical Systems | 04/29/1988SE |
| K873673 | BV105 (&BV105R) Vascular Flow Detector W/OptionalDPT · Traditional | Sonicaid, Inc. | 02/26/1988SE |
| K872441 | High Freq Linear Array(Hfla)Scanhead W/Dplr SidearDPT · Traditional | Advanced Technology Laboratories, Inc. | 02/19/1988SE |
| K871912 | Pv-Lab, Model PVL-1, Peripheral Vascular SystemDPT · Traditional | Electro-Diagnostic Instruments | 02/18/1988SE |
| K873041 | A-V RecorderDPT · Traditional | Life Sciences Manufacturing, Inc. | 02/04/1988SE |
| K863372 | SM-20 Cardioscan Doppler Option with CFM700 ProbesDPT · Traditional | Interspec, Inc. | 11/04/1986SE |
| K860121 | Intravascular Catheter W/Doppler TransducerDPT · Traditional | NuMED, Inc. | 06/02/1986SE |
| K860435 | Model 500A Vascular Spectrum Analyzer W/Cw DopplerDPT · Traditional | Multigon Industries, Inc. | 05/05/1986SE |
| K830858 | Bio-Probe System-Blood Flow ProbeDPT · Traditional | Bio Medicus, Inc. | 06/08/1983SE |
| K792015 | P-2 Ultrasonic ArteriographDPT · Traditional | D. E. Hokanson, Inc. | 12/04/1979SE |
| K781413 | Mask, PxygenDPT · Traditional | Vitalab Products Corp. | 09/07/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0205-2025 Class II | smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0204-2025 Class II | medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0203-2025 Class II | medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0202-2025 Class II | medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0201-2025 Class II | medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0200-2025 Class II | medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0199-2025 Class II | medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0198-2025 Class II | medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0197-2025 Class II | medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA…Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0196-2025 Class II | medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0195-2025 Class II | medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SCDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0194-2025 Class II | medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNTDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0193-2025 Class II | medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFTDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0192-2025 Class II | medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0191-2025 Class II | medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0190-2025 Class II | medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0189-2025 Class II | medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0188-2025 Class II | medex TranStar Disposable Transducer 1/EA, Product Code REF MX950Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0187-2025 Class II | medex Arterial Kit 1/EA, Product Code REF MX7827Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0186-2025 Class II | medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0185-2025 Class II | medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-0184-2025 Class II | medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in… | Smiths Medical ASD, Inc. | 09/24/2024Open, Classified |
| Z-2780-2015 Class II | ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the…The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or… | Edwards Lifesciences, LLC | 08/26/2015Terminated |