# K955417: Vital Pak

- Pathway: 510(k) (Traditional)
- Applicant: Vital Signs, Inc.
- Decided: Mar 8, 1996 after 102 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945455 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945455: General Anesthesia System, Vital Signs, Inc. (1994) Summary page 2.

## Indications for use
The devices are used during the set-up and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.

Source page: https://510kreport.com/device/K955417
Methodology: https://510kreport.com/methodology