Schneider-Shiley Pressure Manometer
FDA 510(k) K861605 · Shiley, Inc.
510(k) numberK861605
Submission
- Device name
- Schneider-Shiley Pressure Manometer
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- April 29, 1986
- Decision date
- May 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRK – Manometer, Blood-Pressure, Venous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1140
- Specialty
- Cardiovascular
Other 510(k)s with product code KRK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950607 | UST-5268P-5 TransducerKRK · Traditional | Aloka Co., Ltd. | 09/15/1995SE |
| K904674 | Central Venous Pressure ManometerKRK · Traditional | Medex, Inc. | 12/27/1990SE |
| K884386 | Administration/Manometer Set W/3 Way StopcockKRK · Traditional | Ethitek Pharmaceuticals Co. | 01/05/1989SE |
| K875322 | Modified Schneider-Shiley Pressure ManometerKRK · Traditional | Schneider-Shilley (Usa) | 03/28/1988SE |
| K830910 | Manometer Set C.V.P. #S 298/299KRK · Traditional | Exco, Inc. | 04/05/1983SE |
| K813498 | MedifixKRK · Traditional | Burron Medical Products, Inc. | 01/07/1982SE |
| K813195 | Medifix Graduated ScaleKRK · Traditional | Burron Medical Products, Inc. | 12/29/1981SE |
| K790668 | Venous Pressure Monitor, MF 35 LFKRK · Traditional | Deco Medical, Inc. | 05/23/1979SE |
More from Deco Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
Questions and answers
When was Schneider-Shiley Pressure Manometer cleared by the FDA?
Schneider-Shiley Pressure Manometer (K861605) received a 510(k) decision of Substantially Equivalent on May 28, 1986, 29 days after the submission was received.
What is the product code of K861605?
The FDA product code is KRK – Manometer, Blood-Pressure, Venous, a Class II (moderate risk) device regulated under 21 CFR 870.1140.