510(k) · Cleared

Cleared

Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225, and B300

K972878510(k) TraditionalCleared Oct 30, 199787-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

Safety Syringes, Inc. · FMF Syringe, Piston

Cleared on Oct 30, 1997 as substantially equivalent to K944425 (Safety Syringes, Inc., 1995) after an 87-day review. Its family tree reaches back 1 generation to 1995.

Decided: Oct 30, 1997
Review: 87 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K944425 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK944425 Ultrasafe Aspirating SyringeSafety Syringes, Inc. · 1995
This deviceK972878 Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225…Safety Syringes, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944425	Ultrasafe Aspirating Syringe	Safety Syringes, Inc.	1995	—
0 (this device)	K972878	Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225, and B300	Safety Syringes, Inc.	1997	—

FIG. 1 — Lineage of K972878, 1995–1997Source: 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
*	K944425	Ultrasafe Aspirating Syringe Summary page 1 …626) 821.1121 Phone (626) 821.1009 Fax 9.2 Device Name UltraSafe® Injection System Needle Guard 9.3 Predicate Devices Safety Syringes UltraSafe® Aspirating Syringe - K944425 9.4 Product Description and Function The UltraSafe® Needle Guerd is an accessory to the ISO 11040-4 standard glass syringe that…	Safety Syringes, Inc.	1995	—

Also cleared against K944425: 2 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?

Its one ancestor has no recall.
2 other devices also cite its predicate K944425.

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?

Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and

parenteral methods of administration.

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/K972878 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972878: Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225, and B300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972878

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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