510(k) Report

510(k) · Cleared

Cleared

Terumo U-100 Insulin Syringe

K992802510(k) SpecialCleared Sep 9, 199921-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 Sep 9, 1999 as substantially equivalent to K822083 (Terumo Medical Corp., 1982) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1982. 84 later devices descend from it.

Decided
Sep 9, 1999
Review
21 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K822083 (1982). 2 ancestors in all. 84 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor2008: 2 descendants cleared2007: 1 descendant cleared2017: 5 descendants cleared2009: 1 descendant cleared2016: 3 descendants cleared2011: 4 descendants cleared2018: 3 descendants cleared2015: 1 descendant cleared2021: 13 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2023: 15 descendants cleared2019: 2 descendants cleared2022: 13 descendants cleared2020: 4 descendants cleared2024: 6 descendants cleared2025: 6 descendants cleared2026: 3 descendants clearedK822083 · U-100 Insulin Syringe · Terumo Medical Corp. · 198219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 12 descendants4 generations forward: 24 descendants5 generations forward: 30 descendants6 generations forward: 9 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K822083 · U-100 Insulin Syringe · Terumo Medical Corp. · 19820+5
  1. Root · 1 generation backK822083 U-100 Insulin SyringeTerumo Medical Corp. · 1982
  2. This deviceK992802 Terumo U-100 Insulin SyringeTerumo Medical Corp. · 1999
  3. Descendant · cites it directly · 82 of its ownK071630 Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp. · 2007
  4. Descendant · 2 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
  5. Descendant · 3 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
  6. Descendant · 3 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
  7. Descendant · 4 generations on · 13 of its ownK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12011: 42012: 12013: 12015: 12016: 32017: 52018: 32019: 22020: 42021: 132022: 132023: 152024: 62025: 62026: 3
2007high 15 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 84 · See all
  • K071630Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp. · 2007 · cites it directly82descendants
  • K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 2 generations on78descendants
  • K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 3 generations on36descendants
  • K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 3 generations on31descendants
  • K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd. · 2019 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K822083U-100 Insulin SyringeTerumo Medical Corp.1982—
0 (this device)K992802Terumo U-100 Insulin SyringeTerumo Medical Corp.1999—
+1K071630Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp.2007—
+2K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.2008—
+3K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.2011—
+3K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,2011—
+4K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile…Shanghai Kohope Medical Devices Co., Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201140
201210
201310
201510
201630
201750
201830
201920
202040
2021130
2022130
2023150
202460
202560
202630
FIG. 1 — Lineage of K992802, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K822083U-100 Insulin Syringe
Summary page 1
…tially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Medical Corporation U-100 Insulin syringe (K822083). There is no intended change in how this device is used. With respect to the 30G x 3/8” cannula, the Terumo U-100 Insulin Syrin…
Terumo Medical Corp.1982—
*K955235B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe
Summary page 1
…Terumo U-100 Insulin Syringe submitted in this 510k is substantially equivalent to the cleared Becton Dickinson® Ultra Fine II Insulin Syringe with 30G x 5/16” cannula (K955235). PRINCIPLE OF OPERATION/TECHNOLOGY The Terumo U-100 Insulin Syringe is operated manually. MATERIALS The materials used in th…
Bd Becton Dickinson Vacutainer Systems Preanalytic19961

Also cleared against K822083: 3 other devices →

What descends from it? (84)

See all 84

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

NumberDeviceApplicantDecidedDescendants
K071630Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp.200782
K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K071630 (Terumo Medical Corp., 2007) has gone furthest, with 82 descendants of its own.
  • 3 other devices also cite its predicate K822083.

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 TERUMO® U-100 Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K822083

3 other devices cite the same predicate.

  • K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008
  • K071630Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp. · 2007
  • K024249Terumo Surguard Safety SyringeTerumo Medical Corp. · 2003

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/K992802 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992802: Terumo U-100 Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992802

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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