510(k) · Cleared

Cleared

Terumo Allergy Syringe

K980796510(k) TraditionalCleared Apr 2, 199831-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

Cleared on Apr 2, 1998 as substantially equivalent to K941657 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 31-day review. Its family tree reaches back 1 generation to 1994. 1 of the 9 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.

Decided: Apr 2, 1998
Review: 31 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K941657 (1994). 7 later devices descend from it, 3 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
This deviceK980796 Terumo Allergy SyringeTerumo Corp. · 1998
Descendant · cites it directly · 3 of its ownK024249 Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003
Descendant · 2 generations on · 2 of its ownK063755 Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · Recalled (Class I)
Descendant · cites it directly · 1 of its ownK110456 Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
Descendant · 2 generations on · 0 of its ownK121270 Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
Descendant · 3 generations on · 0 of its ownK093176 Med-LokSta-Med, LLC · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003high 2 (2007) · low 0 (2004)2026

Class I recalls in this family

K063755 Portex Hypodermic Needle-Pro Fixed Needle Syringe2 generations on · 2007

Most influential descendants

Showing 5 of 7 · See all

K024249Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003 · cites it directly3descendants
K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · 2 generations on2descendants
K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011 · cites it directly1descendant
K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012 · 2 generations on0descendants
K093176Med-LokSta-Med, LLC · 2010 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941657	BD Micro Fine, Ultra Fine, and Allergy Syringe	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	—
0 (this device)	K980796	Terumo Allergy Syringe	Terumo Corp.	1998	—
+1	K024249	Terumo Surguard Safety Syringe	Terumo Medical Corp.	2003	—
+2	K063755	Portex Hypodermic Needle-Pro Fixed Needle Syringe	Smiths Medical Asd, Inc.	2007	Class I
+1	K110456	Pharmajet 0.1 ML Intradermal Needle-Free Injection System	Pharmajet, Inc.	2011	—
+2	K121270	Bioject Needle-Free Injection Management System	Bioject Medical Technologies, Inc.	2012	—
+3	K093176	Med-Lok	Sta-Med, LLC	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	2	1
2010	2	0
2011	1	0
2012	1	0

FIG. 1 — Lineage of K980796, 1994–2012Source: 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.

1 device in this family has a Class I recall. 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
*	K941657	BD Micro Fine, Ultra Fine, and Allergy Syringe Summary page 2 …valent in intended use, design, specifications, technology/principles of operation, materials and performance to the cleared B-D® Allergy syringe which is the subject of K941657. The Terumo Allergy Syringe and the B-D Allergy Syringe are both operated manually or by a manual process. MATERIALS Barrel Po…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	—

Also cleared against K941657: 7 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K024249	Terumo Surguard Safety Syringe	Terumo Medical Corp.	2003	3
K110456	Pharmajet 0.1 ML Intradermal Needle-Free Injection System	Pharmajet, Inc.	2011	1
K092746	Micronjet 600	Nanopass Technologies, Ltd.	2010	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K024249 (Terumo Medical Corp., 2003) has gone furthest, with 3 descendants of its own.
7 other devices also cite its predicate K941657.

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 Allergy Syringe is intended for the preparation/mixing of allergenic

extracts/prescribed substances, the manual aspiration of fluids, and for the injection of

fluids into parts of the body below the surface of the skin. This 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/K980796 · printed Nov 3, 2026

Cite this page

510(k) Report. “K980796: Terumo Allergy Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K980796

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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