510(k) · Cleared

Cleared

Merit Medical 1-ML Syringe

K024052510(k) AbbreviatedCleared Feb 21, 200377-day reviewClass II21 CFR 880.5860

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

Merit Medical Systems, Inc. · FMF Syringe, Piston

Cleared on Feb 21, 2003 as substantially equivalent to K980580 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) after a 77-day review. Its family tree reaches back 1 generation to 1998. 2 of the 113 devices in its family, counting itself, have a Class I recall. 111 later devices descend from it.

Decided: Feb 21, 2003
Review: 77 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K980580 (1998). 111 later devices descend from it, 3 citing it directly. 2 of the 113 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
This deviceK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
Descendant · cites it directly · 88 of its ownK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
Descendant · 2 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
Descendant · 3 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
Descendant · 2 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
Descendant · cites it directly · 18 of its ownK070856 Icu Medical Single-Use SyringeIcu Medical, Inc. · 2007

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

2007high 17 (2023) · low 0 (2009)2026

Class I recalls in this family

K081361 Chemoclave Cytotoxic Medication Preparation and…2 generations on · 2008
K131549 Chemolock, Chemolock Port3 generations on · 2013

Most influential descendants

Showing 5 of 111 · See all

K070936Welmed Hypodermic SyringeWelmed, Inc. · 2007 · cites it directly88descendants
K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 2 generations on78descendants
K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 3 generations on36descendants
K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 2 generations on31descendants
K070856Icu Medical Single-Use SyringeIcu Medical, Inc. · 2007 · cites it directly18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K980580	Becton Dickinson Syringes	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	—
0 (this device)	K024052	Merit Medical 1-ML Syringe	Merit Medical Systems, Inc.	2003	—
+1	K070936	Welmed Hypodermic Syringe	Welmed, Inc.	2007	—
+2	K072739	Jierui Syringes and Needles	Shandong Weigao Group Medical Polymer Co., Ltd.	2008	—
+3	K110421	Disposable Insulin Syringe	Wenzhou Wuzhou Import & Export Co., Ltd.	2011	—
+2	K112057	KDL Syringes and Needle	Shanghai Kindly Enterprise Dev. Group Co.,	2011	—
+1	K070856	Icu Medical Single-Use Syringe	Icu Medical, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	2	1
2011	5	0
2012	1	0
2013	2	1
2014	1	0
2015	3	0
2016	3	0
2017	8	0
2018	8	0
2019	2	0
2020	6	0
2021	15	0
2022	14	0
2023	17	0
2024	9	0
2025	9	0
2026	4	0

FIG. 1 — Lineage of K024052, 1998–2026Source: 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.

2 devices in this family have 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 FMF device

#1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 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
*	K980580	Becton Dickinson Syringes Summary page 1 …inge Common Name Syringe, Hypodermic Syringe Classification Name Piston Syringe (21 CFR 880.5860) 4. Predicate Device(s) K980580, Becton Dickinson (BD) single-use Hypodermic and Insulin Syringes 5. Device Description Merit Medical Syste…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	—

Also cleared against K980580: 8 other devices →

What descends from it? (111)

See all 111

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

Number	Device	Applicant	Decided	Descendants
K070936	Welmed Hypodermic Syringe	Welmed, Inc.	2007	88
K070856	Icu Medical Single-Use Syringe	Icu Medical, Inc.	2007	18
K111091	Merit Medical 20 ML Syringe	Merit Medical Systems, Inc.	2011	4

Has anything in its family been recalled? (2 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.

K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K070936 (Welmed, Inc., 2007) has gone furthest, with 88 descendants of its own.
8 other devices also cite its predicate K980580.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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	23	90	6	674
2008	9	74	11	691
2009	14	94	15	913
2010	11	130	12	679
2011	16	109	3	186
2012	9	86	6	307
2013	12	154	1	326
2014	13	84	1	244
2015	11	87	2	273
2016	12	146	0	684
2017	13	135	3	1,858
2018	8	87	2	3,952
2019	11	146	1	5,863
2020	15	107	2	5,334
2021	20	175	1	5,874
2022	24	211	2	5,233
2023	22	173	19 (18)	5,214
2024	14	130	0	5,122
2025	13	114	0	4,181
2026	9	239	2 (1)	—

What is it indicated for?

Merit Medical I-mL Syringes are used to inject fluids into, or withdraw fluids from, the body.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024052 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024052: Merit Medical 1-ML Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024052

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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