510(k) · Cleared

Recalled · 2002

Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/ML

K003245510(k) SpecialCleared Dec 4, 200048-day reviewClass II21 CFR 880.5200Recalls 2

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

Baxter Healthcare Corp · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Dec 4, 2000 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 2 times.

Decided: Dec 4, 2000
Review: 48 days
Class: Class II
Product code: FOZ
Recalls: 2
Predicates: 0

8 later devices descend from it, 3 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

This deviceK003245 Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush…Baxter Healthcare Corp · 2000
Descendant · cites it directly · 5 of its ownK013556 Monoject Prefill Heparin Lock Flush SyringeTyco Healthcare · 2001
Descendant · cites it directly · 3 of its ownK011967 BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection…Bd · 2002
Descendant · 2 generations on · 2 of its ownK032438 Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe…Tyco Healthcare · 2004 · Recalled (Class I)
Descendant · 2 generations on · 1 of its ownK090680 Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush…Becton, Dickinson & CO · 2009
Descendant · 3 generations on · 0 of its ownK163591 BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2001high 1 (2001) · low 0 (2005)2026

Class I recalls in this family

K032438 Modification to: Monojet Prefill 0.9% Sodium…2 generations on · 2004

Most influential descendants

Showing 5 of 8 · See all

K013556Monoject Prefill Heparin Lock Flush SyringeTyco Healthcare · 2001 · cites it directly5descendants
K011967BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeBd · 2002 · cites it directly3descendants
K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…Tyco Healthcare · 2004 · 2 generations on2descendants
K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 2009 · 2 generations on1descendant
K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003245	Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp…	Baxter Healthcare Corp	2000	—
+1	K013556	Monoject Prefill Heparin Lock Flush Syringe	Tyco Healthcare	2001	—
+1	K011967	BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe	Bd	2002	—
+2	K032438	Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet…	Tyco Healthcare	2004	Class I
+2	K090680	Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe	Becton, Dickinson & CO	2009	—
+3	K163591	BD PosiFlush Heparin Lock Flush Syringe	Becton, Dickinson and Company	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2004	1	1
2006	1	0
2009	1	0
2010	1	0
2017	1	0

FIG. 1 — Lineage of K003245, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

1 device in this family has a Class I recall. 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 FOZ device

#1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013556	Monoject Prefill Heparin Lock Flush Syringe	Tyco Healthcare	2001	5
K011967	BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe	Bd	2002	3
K032417	Heparin Lock Flush Syringe	Am2 Pat, Inc.	2003	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 12, 2002	Not classified	Z-0457-03	Other	Sterility questioned
Dec 12, 2002	Not classified	Z-0458-03	Other	Sterility questioned

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush SyringeTyco Healthcare · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

Of its descendants, K013556 (Tyco Healthcare, 2001) has gone furthest, with 5 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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	6	159	16	374
2008	9	103	0	422
2009	9	30	23	508
2010	3	28	115	370
2011	6	132	0	786
2012	13	122	0	560
2013	4	104	2	640
2014	9	99	4	815
2015	10	107	0	729
2016	9	63	3 (1)	925
2017	9	51	22	1,966
2018	1	—	4	3,305
2019	8	140	3	4,365
2020	10	191	3	3,797
2021	4	242	1	4,674
2022	8	183	4 (2)	4,133
2023	9	129	4 (2)	4,430
2024	6	190	0	4,772
2025	11	91	0	5,110
2026	7	203	2	—

https://510kreport.com/device/K003245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003245: Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003245

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026