510(k) · Cleared

Cleared

Ultrasafe Injection System Model C200 Injector with Needle Guard

K972877510(k) TraditionalCleared Feb 26, 1998206-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 Feb 26, 1998 as substantially equivalent to K944425 (Safety Syringes, Inc., 1995) after a 206-day review. Its family tree reaches back 1 generation to 1995.

Decided: Feb 26, 1998
Review: 206 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 deviceK972877 Ultrasafe Injection System Model C200 Injector with Needle GuardSafety Syringes, Inc. · 1998

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)	K972877	Ultrasafe Injection System Model C200 Injector with Needle Guard	Safety Syringes, Inc.	1998	—

FIG. 1 — Lineage of K972877, 1995–1998Source: 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? (2)

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 …e (626) 821.1009 Fax Device Name UltraSafe® Injection System, Model C200 Injector with Needle Guard Predicate Devices Safety Syringes UltraSafe® Aspirating Syringe - K944425 Sanofi-Winthrop Injector - Pre-amendment Product Description and Function The UltraSafe® Model C200 Injector with Needle Guard…	Safety Syringes, Inc.	1995	—
*	—	Sanofi-Winthrop Injector Named without a submission number			—

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?

The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needie sticks after injection and during disposal of the needle cartridge unit.

The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to aduits and for a wide range of clinical conditions.

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/K972877 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972877: Ultrasafe Injection System Model C200 Injector with Needle Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972877

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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