510(k) · Cleared

Cleared

Hypodermic Syringe

K771205510(k) TraditionalCleared Jul 14, 19779-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

Terumo America, Inc. · FMF Syringe, Piston

Cleared on Jul 14, 1977 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 92 later devices descend from it.

Decided: Jul 14, 1977
Review: 9 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 0

92 later devices descend from it, 6 citing it directly.

This deviceK771205 Hypodermic SyringeTerumo America, Inc. · 1977
Descendant · cites it directly · 88 of its ownK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
Descendant · cites it directly · 74 of its ownK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
Descendant · 2 generations on · 73 of its ownK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
Descendant · 2 generations on · 67 of its ownK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
Descendant · cites it directly · 65 of its ownK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

1996high 19 (2022) · low 0 (1999)2026

Most influential descendants

Showing 5 of 92 · See all

K980181Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · cites it directly88descendants
K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003 · cites it directly74descendants
K023271Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002 · 2 generations on73descendants
K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004 · 2 generations on67descendants
K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005 · cites it directly65descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K771205	Hypodermic Syringe	Terumo America, Inc.	1977	—
+1	K980181	Terumo Disposable Hypodermc Syringe	Terumo Medical Corp.	1998	1
+1	K031453	Terumo Surguard 2 Safety Needle	Terumo Medical Corp.	2003	—
+2	K023271	Terumo Syringe with/Without Needle	Terumo Medical Corp.	2002	—
+2	K040531	Terumo SURGUARD2 Safety Needle	Terumo Medical Corp.	2004	—
+1	K051865	Terumo Surguard 2 Safety Needle or Similar	Terumo Medical Corp.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	1	0
2002	2	0
2003	2	0
2004	1	0
2005	3	0
2006	2	0
2007	3	0
2008	1	0
2009	3	0
2011	3	0
2012	2	0
2013	2	0
2015	2	0
2017	1	0
2018	2	0
2019	3	0
2020	4	0
2021	7	0
2022	19	0
2023	7	0
2024	8	0
2025	6	0
2026	6	0

FIG. 1 — Lineage of K771205, 1977–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (92)

See all 92

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

Number	Device	Applicant	Decided	Descendants
K980181	Terumo Disposable Hypodermc Syringe	Terumo Medical Corp.	1998	88
K031453	Terumo Surguard 2 Safety Needle	Terumo Medical Corp.	2003	74
K051865	Terumo Surguard 2 Safety Needle or Similar	Terumo Medical Corp.	2005	65
K092986	Acacia Piston Syringe	Acacia, Inc.	2009	0
K972285	Gettig Styrl-Ject Delivery System	Gettig Pharmaceutical Instrument Co.	1997	0
K953940	Terumo Retractable Needle (RN) Syringe	Terumo Medical Corp.	1996	0

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?

Of its descendants, K980181 (Terumo Medical Corp., 1998) has gone furthest, with 88 descendants 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.

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)	—

https://510kreport.com/device/K771205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K771205: Hypodermic Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771205

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026