510(k) · Cleared

Recalled · Class II · 2022

Imc Piston Syringes

K102969510(k) SpecialCleared Dec 20, 201075-day reviewClass II21 CFR 880.5860Recalls 40

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

International Medsurg Connection · FMF Syringe, Piston

Cleared on Dec 20, 2010 as substantially equivalent to K022159 (International Medsurg Connection, 2002) after a 75-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it. It has been recalled 40 times.

Decided: Dec 20, 2010
Review: 75 days
Class: Class II
Product code: FMF
Recalls: 40
Predicates: 1

Its longest line of descent runs back 1 generation to K022159 (2002). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK022159 Piston Syringe & Hypodermic NeedleInternational Medsurg Connection · 2002
This deviceK102969 Imc Piston SyringesInternational Medsurg Connection · 2010
Descendant · cites it directly · 1 of its ownK111841 Shifeng Disposable Syringe with or Without NeedleChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · 2012
Descendant · 2 generations on · 0 of its ownK133493 Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014

Most influential descendants

Showing 2 of 2 · See all

K111841Shifeng Disposable Syringe with or Without NeedleChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · 2012 · cites it directly1descendant
K133493Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022159	Piston Syringe & Hypodermic Needle	International Medsurg Connection	2002	—
0 (this device)	K102969	Imc Piston Syringes	International Medsurg Connection	2010	—
+1	K111841	Shifeng Disposable Syringe with or Without Needle	Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.	2012	—
+2	K133493	Single Use Sterile Syringe with Needle	Jiangxi Kelun Medical Devices Manufacturing Co.,Lt	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0

FIG. 1 — Lineage of K102969, 2002–2014Source: 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 FMF? 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

Get a 510(k) Report

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
*	K022159	Piston Syringe & Hypodermic Needle Summary page 1 …ly marketed: Description 5 10(k) Number Clearance Date IMC piston syringe K022159 11/7/2002 Device Description The device consists of a calibrated hollow barrel and a movable plunger with piston. At…	International Medsurg Connection	2002	—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111841	Shifeng Disposable Syringe with or Without Needle	Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.	2012	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 15, 2022	Class II	Z-0939-2023	Process control	Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Dec 15, 2022	Class II	Z-0938-2023	Process control	Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Jun 23, 2017	Class II	Z-2856-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2839-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2857-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2830-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2851-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2854-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2842-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2862-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2836-201	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2831-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2846-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2844-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2858-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2847-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2828-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2840-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2843-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2853-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2829-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2845-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2834-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2859-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2832-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2850-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2827-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2860-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2837-201	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2848-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2852-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2825-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2861-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2849-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2838-201	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2833-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2826-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2855-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2841-2017	Under Investigation by firm	Insufficient documentation to support product sterility claims.
Jun 23, 2017	Class II	Z-2835-201	Under Investigation by firm	Insufficient documentation to support product sterility claims.

The 5 latest of 40 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K111841 (Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd., 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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?

International Medsurg Connection's piston syringe is intended for the injection of fluids into, or withdraw of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. The intended use is the same as…

Read the full statement (143 words)

'[his submission includes piston syringe that will be sold both sterilc and non-sterile. Non-sterile syringes are to be sold to OEMs for Eta sterilization according to their validated process per ANSI/AMMIIISO 11135. Sterile syringes are to be sold directly to users after £0 sterilization validation per ANSI/AMMI/ISO 11135

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102969 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102969: Imc Piston Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102969

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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