510(k) Report

510(k) · Cleared

Cleared

Terumo Syringe with/Without Needle

K023271510(k) AbbreviatedCleared Dec 18, 200278-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 Medical Corp. · FMF Syringe, Piston

Cleared on Dec 18, 2002 as substantially equivalent to K980181 (Terumo Medical Corp., 1998) after a 78-day review. Its family tree reaches back 2 generations to 1977. 73 later devices descend from it.

Decided
Dec 18, 2002
Review
78 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K771205 (1977). 73 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2011: 3 descendants cleared2012: 2 descendants cleared2019: 3 descendants cleared2018: 2 descendants cleared2013: 2 descendants cleared2017: 1 descendant cleared2026: 6 descendants cleared2022: 19 descendants cleared2015: 2 descendants cleared2020: 4 descendants cleared2021: 6 descendants cleared2025: 6 descendants cleared2023: 7 descendants cleared2024: 6 descendants clearedK771205 · Hypodermic Syringe · Terumo America, Inc. · 1977K980181 · Terumo Disposable Hypodermc Syringe · Terumo Medical Corp. · 1998 · recalled19801990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 15 descendants4 generations forward: 26 descendants5 generations forward: 18 descendants6 generations forward: 3 descendants K980181 · Terumo Disposable Hypodermc Syringe · Terumo Medical Corp. · 1998 · recalledK771205 · Hypodermic Syringe · Terumo America, Inc. · 19770+5
  1. Root · 2 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
  2. 1 generation backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
  3. This deviceK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
  4. Descendant · cites it directly · 65 of its ownK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
  5. Descendant · 2 generations on · 60 of its ownK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
  6. Descendant · cites it directly · 39 of its ownK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
  7. Descendant · cites it directly · 36 of its ownK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
  8. Descendant · cites it directly · 34 of its ownK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12009: 12011: 32012: 22013: 22015: 22017: 12018: 22019: 32020: 42021: 62022: 192023: 72024: 62025: 62026: 6
2005high 19 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 73 · See all
  • K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005 · cites it directly65descendants
  • K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012 · 2 generations on60descendants
  • K052034Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005 · cites it directly39descendants
  • K063613Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006 · cites it directly36descendants
  • K083514Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009 · cites it directly34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K771205Hypodermic SyringeTerumo America, Inc.1977—
−1K980181Terumo Disposable Hypodermc SyringeTerumo Medical Corp.19981
0 (this device)K023271Terumo Syringe with/Without NeedleTerumo Medical Corp.2002—
+1K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp.2005—
+2K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with…Terumo (Philippines) Corporation2012—
+1K052034Terumo Syringe with/Without NeedleTerumo Medical Corp.2005—
+1K063613Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp.2006—
+1K083514Terumo Syringe with/Without NeedleTerumo Europe N.V.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200910
201130
201220
201320
201520
201710
201820
201930
202040
202160
2022190
202370
202460
202560
202660
FIG. 1 — Lineage of K023271, 1977–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K980181Terumo Disposable Hypodermc Syringe
Summary page 1
…market notification is substantially equivalent to the predicate device, Terumo Medical Corporation Hypodermic Syringe, which is legally marketed and was cleared by FDA (K980181). Intended Use: The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or wit…
Terumo Medical Corp.19981

Also cleared against K980181: 5 other devices →

What descends from it? (73)

See all 73

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

NumberDeviceApplicantDecidedDescendants
K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp.200565
K052034Terumo Syringe with/Without NeedleTerumo Medical Corp.200539
K063613Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp.200636
K083514Terumo Syringe with/Without NeedleTerumo Europe N.V.200934

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?

  • The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 20.7 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K051865 (Terumo Medical Corp., 2005) has gone furthest, with 65 descendants of its own.
  • 5 other devices also cite its predicate K980181.

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

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
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

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

The Terunio Syringe with/without needle is intended to be used €or medical purposes to inject fluids into or withdraw fluids from the body.

Indications for use as stated in the FDA summary.

Also cleared against K980181

5 other devices cite the same predicate.

  • K053413Terumo Syringe for Administration of UV Sensitive MedicinesTerumo Europe N.V. · 2006
  • K052551Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc. · 2005
  • K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
  • K021993Shanchuan SyringeShangdong Zibo Shanchuan Medical Instruments Co. · 2003
  • K022495Gettig Disposable SyringesGettig Pharmaceutical Instrument Co. · 2002

More from Terumo Medical Corp.

143 FDA decisions under this applicant name. See the company

  • K111606Pinnacle Precision Access SystemTerumo Medical Corp. · 20111 recall
  • K111556Glidecross Support CatheterTerumo Medical Corp. · 2011
  • K110540Terumo Support CatheterTerumo Medical Corp. · 2011
  • K102008GlidesheathTerumo Medical Corp. · 20101 recall
  • K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 20091 recall

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K023271 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023271: Terumo Syringe with/Without Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023271

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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