510(k) · Cleared

Recalled · Class II · 2015

Terumo Disposable Hypodermc Syringe

K980181510(k) TraditionalCleared Apr 2, 199872-day reviewClass II21 CFR 880.5860Recalls 1

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

Terumo Medical Corp. · FMF Syringe, Piston

Cleared on Apr 2, 1998 as substantially equivalent to K771205 (Terumo America, Inc., 1977) after a 72-day review. Its family tree reaches back 1 generation to 1977. 88 later devices descend from it. It has been recalled once.

Decided: Apr 2, 1998
Review: 72 days
Class: Class II
Product code: FMF
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K771205 (1977). 88 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
This deviceK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998
Descendant · cites it directly · 74 of its ownK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
Descendant · cites it directly · 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 · 2 generations on · 65 of its ownK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
Descendant · 3 generations on · 60 of its ownK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

2002high 19 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 88 · See all

K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003 · cites it directly74descendants
K023271Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002 · cites it directly73descendants
K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004 · 2 generations on67descendants
K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005 · 2 generations on65descendants
K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012 · 3 generations on60descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K771205	Hypodermic Syringe	Terumo America, Inc.	1977	—
0 (this device)	K980181	Terumo Disposable Hypodermc Syringe	Terumo Medical Corp.	1998	—
+1	K031453	Terumo Surguard 2 Safety Needle	Terumo Medical Corp.	2003	—
+1	K023271	Terumo Syringe with/Without Needle	Terumo Medical Corp.	2002	—
+2	K040531	Terumo SURGUARD2 Safety Needle	Terumo Medical Corp.	2004	—
+2	K051865	Terumo Surguard 2 Safety Needle or Similar	Terumo Medical Corp.	2005	—
+3	K113422	Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with…	Terumo (Philippines) Corporation	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	2	0
2004	1	0
2005	3	0
2006	2	0
2007	3	0
2008	1	0
2009	2	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 K980181, 1977–2026Source: 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 16.2 · 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
*	K771205	Hypodermic Syringe Summary page 1 …ds into or withdrawing fluids from the body. The syringe is designed for manual use. Note: This is the same intended use as the Terumo Hypodermic Syringe cleared under K771205. DESCRIPTION The Terumo Disposable Hypodermic -Syringe, with or without a hypodermic single lumen needle, is a sterile, single…	Terumo America, Inc.	1977	—

Also cleared against K771205: 5 other devices →

What descends from it? (88)

See all 88

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

Number	Device	Applicant	Decided	Descendants
K031453	Terumo Surguard 2 Safety Needle	Terumo Medical Corp.	2003	74
K023271	Terumo Syringe with/Without Needle	Terumo Medical Corp.	2002	73
K053413	Terumo Syringe for Administration of UV Sensitive Medicines	Terumo Europe N.V.	2006	36
K021993	Shanchuan Syringe	Shangdong Zibo Shanchuan Medical Instruments Co.	2003	1
K052551	Devon Standard Syringe, Hypodermic Needle and Insulin Syringe	Devon Safety Products, Inc.	2005	0
K022495	Gettig Disposable Syringes	Gettig Pharmaceutical Instrument Co.	2002	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 21, 2015	Class II	Z-0731-2016	Packaging process control	All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K031453 (Terumo Medical Corp., 2003) has gone furthest, with 74 descendants of its own.
5 other devices also cite its predicate K771205.

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 Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.

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/K980181 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980181: Terumo Disposable Hypodermc Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980181

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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