510(k) · Cleared

Cleared

Patient Safe Syringe

K072654510(k) TraditionalCleared Dec 14, 200785-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

Retractable Technologies, Inc. · FMF Syringe, Piston

Cleared on Dec 14, 2007 as substantially equivalent to K030683 (Nipro Medical Corp., 2003) after an 85-day review. Its family tree reaches back 2 generations to 1994.

Decided: Dec 14, 2007
Review: 85 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K944355 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
1 generation backK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
This deviceK072654 Patient Safe SyringeRetractable Technologies, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944355	Nipro Branded Disposable Syringes, Needles	Nissho Corp.	1994	—
−1	K030683	Nipro Disposable Syringes	Nipro Medical Corp.	2003	—
0 (this device)	K072654	Patient Safe Syringe	Retractable Technologies, Inc.	2007	—

FIG. 1 — Lineage of K072654, 1994–2007Source: 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

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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
*	K030683	Nipro Disposable Syringes Summary page 1 …Piston Syringe Device Classification: Class 1I Legally Marketed Substantially Equivalent Device: Nipro Disposable Syringes (K030683) Description of Device: The Patient Safe SyringeTM is a 3 piece piston syringe consisting of…	Nipro Medical Corp.	2003	—

Also cleared against K030683: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K030683.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

The intended use of the Patient Safe SyringeTM is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072654: Patient Safe Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072654

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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