# K973593: Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration, Bridge Sentry Administration Set 5

- Pathway: 510(k) (Traditional)
- Applicant: Bridge Medical, Inc.
- Decided: Aug 25, 1998 after 337 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K820963 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820963: Patient Pal I.V. Walker, Pryor Products (1982) Summary page 1.
- K946201: Stand, Infusion, Medical Specialties, Inc. (1995) Summary page 1.
- K933335: River Vial Adapter, River Medical, Inc. (1994) Summary page 1.
- K900865: Add-a-Vial II Binary Connector, Kendall Mcgaw Laboratories, Inc. (1990) Summary page 1.
- K904225: Kwikmix, Baxa Corp., Sub. of Cook Group, Inc. (1990) Summary page 1.
- K852488: Controlled Release Infusion System (Cris), Y (1985) Summary page 2.
- (no number) Horizon Nxt: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K900467: Lifecare Model 4 Pump, Abbott Laboratories (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K804568: McGaw, Inc. / Volumetric Infusion Pump and IV Set. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Indications for use
The Bridge Sentry™ System Is intended for the infusion (or administration) of fluids or medications. It is also intended for the preparation (reconstitution, as required, and mixing) of single dose, anti-infective and gastrointestinal drugs. it is not intended for use with blood, blood products or lipids.

Source page: https://510kreport.com/device/K973593
Methodology: https://510kreport.com/methodology