Spectramed Model SP1455 HEMOPRO2 System
FDA 510(k) K865101 · Spectramed, Inc.
510(k) numberK865101
Submission
- Device name
- Spectramed Model SP1455 HEMOPRO2 System
- Applicant
- Spectramed, Inc.
St. Louis Park, MN, US - Received
- December 30, 1986
- Decision date
- April 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K251275 | VitalStream ART Connect; VitalStream-HemoDXG · Traditional | Caretaker Medical | 09/26/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | Icu Medical | 12/20/2023SE |
| K212529 | Hypotension Decision Assist Model HDA-OR2DXG · Special | Directed Systems, Ltd. | 11/23/2021SE |
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | Pulsion Medical Systems SE | 04/30/2020SE |
| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
| K190955 | Hypotension Decision AssistDXG · Traditional | Directed Systems, Ltd. | 11/27/2019SE |
| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K896122 | Amnicathdl(Tm) DT-IUPC2 Dual Lumen Trans. TippedKXO · Traditional | 01/19/1990SE |
| K892941 | Cco System Model SP1467,SP5567,SP6267KRB · Traditional | 11/06/1989SE |
| K895323 | Model Dt-Bal, Balance SaverKXO · Traditional | 10/24/1989SE |
| K894362 | Model DT-IUPC2 Transducer Tipped Dual Lumen IupKXO · Traditional | 08/15/1989SE |
| K881857 | Amnicath(Tm) Model Dt-Iupc Trans. Tipped Intrau.KXO · Traditional | 02/01/1989SE |
| K885235 | Safe-Draw(Tm) Blood Sampling Reservoir & Access.DSK · Traditional | 01/25/1989SE |
| K881825 | Models SP5825/SP5835/SP5845/SP5855 Percu. SheathDYB · Traditional | 09/28/1988SE |
| K875337 | Heparin Coated Luminal Pacing CatheterDQO · Traditional | 05/25/1988SE |
| K880740 | Model TA-CS10 Spectraject Control SyringeDQF · Traditional | 03/22/1988SE |
| K873168 | Spectramed Disposable Transducer (Dt-Xxo) & AccessDRS · Traditional | 01/12/1988SE |
Questions and answers
When was Spectramed Model SP1455 HEMOPRO2 System cleared by the FDA?
Spectramed Model SP1455 HEMOPRO2 System (K865101) received a 510(k) decision of Substantially Equivalent on April 20, 1987, 111 days after the submission was received.
What is the product code of K865101?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.