510(k) · Cleared

Cleared

0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe

K003553510(k) TraditionalCleared Mar 21, 2001124-day reviewClass II21 CFR 880.5200

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

Bd Becton Dickinson Vacutainer Systems Preanalytic · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Mar 21, 2001 after a 124-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided: Mar 21, 2001
Review: 124 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 0

10 later devices descend from it, 3 citing it directly.

This deviceK003553 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
Descendant · cites it directly · 7 of its ownK042061 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush SyringeBecton Dickinson · 2004 · Recalled
Descendant · cites it directly · 6 of its ownK121050 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF…Becton, Dickinson & CO · 2013 · Recalled
Descendant · 2 generations on · 3 of its ownK141311 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF…Becton, Dickinson and Company · 2014
Descendant · 3 generations on · 2 of its ownK161552 0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company · 2017 · Recalled
Descendant · 2 generations on · 1 of its ownK153481 0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company · 2016 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004high 2 (2017) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all

K0420610.9% Sodium Chloride Injection, Usp BD Postflush SF Flush SyringeBecton Dickinson · 2004 · cites it directly7descendants
K1210500.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush SyringeBecton, Dickinson & CO · 2013 · cites it directly6descendants
K1413110.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF SyringeBecton, Dickinson and Company · 2014 · 2 generations on3descendants
K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company · 2017 · 3 generations on2descendants
K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company · 2016 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003553	0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe	Bd Becton Dickinson Vacutainer Systems Preanalytic	2001	—
+1	K042061	0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe	Becton Dickinson	2004	13
+1	K121050	0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe	Becton, Dickinson & CO	2013	1
+2	K141311	0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF Syringe	Becton, Dickinson and Company	2014	—
+3	K161552	0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe	Becton, Dickinson and Company	2017	3
+2	K153481	0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe	Becton, Dickinson and Company	2016	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2009	1	0
2013	1	0
2014	1	0
2016	1	0
2017	2	0
2022	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K003553, 2001–2025Source: 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.

Planning a device in FOZ? 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

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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? (10)

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

Number	Device	Applicant	Decided	Descendants
K042061	0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe	Becton Dickinson	2004	7
K121050	0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe	Becton, Dickinson & CO	2013	6
K090680	Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe	Becton, Dickinson & CO	2009	1

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?

Of its descendants, K042061 (Becton Dickinson, 2004) has gone furthest, with 7 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/K003553 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003553: 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003553

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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