510(k) · Cleared

Cleared

Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration, Bridge Sentry Administration Set 5

K973593510(k) TraditionalCleared Aug 25, 1998337-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bridge Medical, Inc. · FRN Pump, Infusion

Cleared on Aug 25, 1998 as substantially equivalent to K820963 (Pryor Products, 1982) and 5 other predicates after a 337-day review. Its family tree reaches back 1 generation to 1982.

Decided: Aug 25, 1998
Review: 337 days
Class: Class II
Product code: FRN
Recalls: None
Predicates: 8

Its longest line of descent runs back 1 generation to K820963 (1982). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK820963 Patient Pal I.V. WalkerPryor Products · 1982
This deviceK973593 Bridge Sentry Bedside Unit, Bridge Sentry Administration…Bridge Medical, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K820963	Patient Pal I.V. Walker	Pryor Products	1982	—
0 (this device)	K973593	Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard…	Bridge Medical, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1990	2	0
1994	1	0
1995	1	0

FIG. 1 — Lineage of K973593, 1982–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FRN device

#1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K820963	Patient Pal I.V. Walker Summary page 1 …ation Name: Infusion Pump; Intravascular Administration, Set, Compounder 3. Predicate Devices The predicate devices are shown in the table below: PRYOR Patient Pal IV K820963 procode FO Walker Medical Specialties, Inc./ \| K946201 procode FOX Infusion Stand River Medical, Inc./ K933335 procode FRN SmartD…	Pryor Products	1982	—
*	K946201	Stand, Infusion Summary page 1 …, Set, Compounder 3. Predicate Devices The predicate devices are shown in the table below: PRYOR Patient Pal IV K820963 procode FO Walker Medical Specialties, Inc./ \| K946201 procode FOX Infusion Stand River Medical, Inc./ K933335 procode FRN SmartDose Drug Vial Adapter N B 7 McGaw, Inc./ ADD-A-VIAL \| K…	Medical Specialties, Inc.	1995	—
*	K933335	River Vial Adapter Summary page 1 …evices are shown in the table below: PRYOR Patient Pal IV K820963 procode FO Walker Medical Specialties, Inc./ \| K946201 procode FOX Infusion Stand River Medical, Inc./ K933335 procode FRN SmartDose Drug Vial Adapter N B 7 McGaw, Inc./ ADD-A-VIAL \| K900865 procode LHI Il Binary Connector BAXA, Inc. / Micr…	River Medical, Inc.	1994	—
*	K900865	Add-a-Vial II Binary Connector Summary page 1 …lker Medical Specialties, Inc./ \| K946201 procode FOX Infusion Stand River Medical, Inc./ K933335 procode FRN SmartDose Drug Vial Adapter N B 7 McGaw, Inc./ ADD-A-VIAL \| K900865 procode LHI Il Binary Connector BAXA, Inc. / MicroMacro K904225 procode LHI 12 Compounder Bridge Medical, Inc. 265 Santa Helena,…	Kendall Mcgaw Laboratories, Inc.	1990	2
*	K904225	Kwikmix Summary page 1 …tand River Medical, Inc./ K933335 procode FRN SmartDose Drug Vial Adapter N B 7 McGaw, Inc./ ADD-A-VIAL \| K900865 procode LHI Il Binary Connector BAXA, Inc. / MicroMacro K904225 procode LHI 12 Compounder Bridge Medical, Inc. 265 Santa Helena, Suite 210, Solana Beach, California 92075 Tel: 619 350 0100 Fax…	Baxa Corp., Sub. of Cook Group, Inc.	1990	—
*	K852488	Controlled Release Infusion System (Cris) Summary page 2 …12 Compounder Bridge Medical, Inc. 265 Santa Helena, Suite 210, Solana Beach, California 92075 Tel: 619 350 0100 Fax: 6193500115 IVAC, Inc. / Controlled K852488 procode FPA Release Infusion System(CRIS) Abbott Laboratories, Inc. / \| KO00467 procode FRN Therapist Infusion System 4000 (OmniF…	Y	1985	—
Kept off the family tree	K900467	FDA’s K900467 is Lifecare Model 4 Pump Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Abbott Laboratories	1990	—
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
*	—	Horizon Nxt Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 6 ancestors has a recall of any class.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	102	15	1,086
2008	8	89	24	8,261
2009	9	66	102	1,952
2010	3	93	37	6,133
2011	3	103	69	41,367
2012	4	217	42 (2)	15,482
2013	6	312	22 (3)	40,082
2014	6	172	4 (3)	94,180
2015	3	232	5	26,742
2016	3	301	7 (1)	16,560
2017	3	305	13	12,060
2018	3	267	1	16,591
2019	2	—	18 (1)	15,850
2020	1	—	16 (5)	94,186
2021	2	—	3 (2)	199,342
2022	6	268	2	888,020
2023	7	265	16 (10)	165,838
2024	5	103	9 (4)	57,730
2025	8	172	7 (4)	52,792
2026	2	—	11 (2)	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973593 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973593: Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration, Bridge Sentry Administration Set 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973593

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026