510(k) · Cleared

Cleared

Monoject Prefill Heparin Lock Flush Syringe

K013556510(k) TraditionalCleared Dec 31, 200167-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

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

Cleared on Dec 31, 2001 as substantially equivalent to K003245 (Baxter Healthcare Corp, 2000) after a 67-day review. Its family tree reaches back 1 generation to 2000. 1 of the 7 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.

Decided: Dec 31, 2001
Review: 67 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003245 (2000). 5 later devices descend from it, 2 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK003245 Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush…Baxter Healthcare Corp · 2000 · Recalled
This deviceK013556 Monoject Prefill Heparin Lock Flush SyringeTyco Healthcare · 2001
Descendant · cites it directly · 2 of its ownK032438 Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe…Tyco Healthcare · 2004 · Recalled (Class I)
Descendant · cites it directly · 1 of its ownK090680 Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush…Becton, Dickinson & CO · 2009
Descendant · 2 generations on · 0 of its ownK163591 BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017
Descendant · 2 generations on · 0 of its ownK090882 Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc. · 2010 · Recalled
Descendant · 2 generations on · 0 of its ownK060339 Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush…Tyco Healthcare/Kendall · 2006 · Recalled

Class I recalls in this family

K032438 Modification to: Monojet Prefill 0.9% Sodium…cites it directly · 2004

Most influential descendants

Showing 5 of 5 · See all

K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…Tyco Healthcare · 2004 · cites it directly2descendants
K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO · 2009 · cites it directly1descendant
K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company · 2017 · 2 generations on0descendants
K090882Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc. · 2010 · 2 generations on0descendants
K060339Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile DeliveryTyco Healthcare/Kendall · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003245	Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp…	Baxter Healthcare Corp	2000	2
0 (this device)	K013556	Monoject Prefill Heparin Lock Flush Syringe	Tyco Healthcare	2001	—
+1	K032438	Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet…	Tyco Healthcare	2004	Class I
+1	K090680	Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe	Becton, Dickinson & CO	2009	—
+2	K163591	BD PosiFlush Heparin Lock Flush Syringe	Becton, Dickinson and Company	2017	—
+2	K090882	Flush Syringe Filled with 0.9% Sodium Chloride	Hospira, Inc.	2010	3
+2	K060339	Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for…	Tyco Healthcare/Kendall	2006	11

Descendants by year cleared

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

FIG. 1 — Lineage of K013556, 2000–2017Source: 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.

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

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003245	Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/ML	Baxter Healthcare Corp	2000	2

Also cleared against K003245: 2 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K032438	Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill… Class I	Tyco Healthcare	2004	2
K090680	Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe	Becton, Dickinson & CO	2009	1

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

No FDA recall names this device.

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 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K032438 (Tyco Healthcare, 2004) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K003245.

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	—

What is it indicated for?

The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

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/K013556 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013556: Monoject Prefill Heparin Lock Flush Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013556

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026