Vital Pak
FDA 510(k) K955417 · Vital Signs, Inc.
510(k) numberK955417
Submission
- Device name
- Vital Pak
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- November 27, 1995
- Decision date
- March 8, 1996
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0)DXG · Traditional | Retia Medical Systems, Inc. | 02/13/2026SE |
| 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 |
|---|---|---|
| K112902 | Enflow IV Fluid WarmerLGZ · Traditional | 03/14/2012SE |
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| K030985 | Breas PV 10I CPAP System, Model PV 10IBZD · Traditional | 10/15/2003SE |
| K022402 | Disposable Pressure ManometerCAP · Traditional | 08/22/2002SE |
| K021315 | Sure-LokFMI · Abbreviated | 08/21/2002SE |
| K002454 | Breas HA50 Humidifier, Model HA50BTT · Abbreviated | 03/07/2001SE |
| K001553 | Breas PV 100 CPAP SystemBZD · Traditional | 08/03/2000SE |
| K000441 | BodyguardFMI · Traditional | 04/11/2000SE |
| K994044 | Cleen-AbleDXQ · Traditional | 02/25/2000SE |
| K990412 | Cuff-Able PlusDXQ · Traditional | 09/01/1999SE |
Questions and answers
When was Vital Pak cleared by the FDA?
Vital Pak (K955417) received a 510(k) decision of Unknown on March 8, 1996, 102 days after the submission was received.
What is the product code of K955417?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.