510(k) Report

510(k) · Cleared

Cleared

Welmed Hypodermic Syringe

K070936510(k) AbbreviatedCleared Jul 16, 2007104-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

Welmed, Inc. · FMF Syringe, Piston

Cleared on Jul 16, 2007 as substantially equivalent to K024052 (Merit Medical Systems, Inc., 2003) after a 104-day review. Its family tree reaches back 2 generations to 1998. 88 later devices descend from it.

Decided
Jul 16, 2007
Review
104 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K980580 (1998). 88 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2017: 6 descendants cleared2018: 4 descendants cleared2008: 1 descendant cleared2016: 3 descendants cleared2015: 1 descendant cleared2021: 13 descendants cleared2013: 1 descendant cleared2019: 2 descendants cleared2023: 15 descendants cleared2024: 8 descendants cleared2020: 5 descendants cleared2025: 7 descendants cleared2022: 14 descendants cleared2012: 1 descendant cleared2026: 4 descendants clearedK980580 · Becton Dickinson Syringes · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998K024052 · Merit Medical 1-ML Syringe · Merit Medical Systems, Inc. · 20031995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 21 descendants3 generations forward: 34 descendants4 generations forward: 22 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants K024052 · Merit Medical 1-ML Syringe · Merit Medical Systems, Inc. · 2003K980580 · Becton Dickinson Syringes · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19980+5
  1. Root · 2 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
  2. 1 generation backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
  3. This deviceK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
  4. Descendant · cites it directly · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
  5. Descendant · 2 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
  6. Descendant · cites it directly · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
  7. Descendant · 2 generations on · 13 of its ownK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019
  8. Descendant · 2 generations on · 12 of its ownK180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic…Berpu Medical Technology Co., Ltd. · 2018

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

2008: 12011: 32012: 12013: 12015: 12016: 32017: 62018: 42019: 22020: 52021: 132022: 142023: 152024: 82025: 72026: 4
2008high 15 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 88 · See all
  • K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · cites it directly78descendants
  • K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 2 generations on36descendants
  • K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · cites it directly31descendants
  • K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd. · 2019 · 2 generations on13descendants
  • K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Berpu Medical Technology Co., Ltd. · 2018 · 2 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K980580Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic1998—
−1K024052Merit Medical 1-ML SyringeMerit Medical Systems, Inc.2003—
0 (this device)K070936Welmed Hypodermic SyringeWelmed, Inc.2007—
+1K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.2008—
+2K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.2011—
+1K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,2011—
+2K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile…Shanghai Kohope Medical Devices Co., Ltd.2019—
+2K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes…Berpu Medical Technology Co., Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201130
201210
201310
201510
201630
201760
201840
201920
202050
2021130
2022140
2023150
202480
202570
202640
FIG. 1 — Lineage of K070936, 1998–2026Source: 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 16.2 · 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
*K024052Merit Medical 1-ML Syringe
Summary page 1
…n Name: Syringes, Hypodermic Classification Name: Piston Syringe (21 CFR 880.5860; Product Code FMF) 4. Predicate Device: Merit Medical Syringe (K024052) 5. Device Description: The Welmed, Inc. Syringe is a device intended for medical purposes, consisting of a calib…
Merit Medical Systems, Inc.2003—

Also cleared against K024052: 2 other devices →

What descends from it? (88)

See all 88

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

NumberDeviceApplicantDecidedDescendants
K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.200878
K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,201131
K173601Merit SyringeMerit Medical Systems, Inc.20184
K163597VacLok AT Vacuum SyringeMerit Medical Systems, Inc.20171
K163084Merit Coronary Control SyringeMerit Medical Systems, Inc.20171

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 9 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K072739 (Shandong Weigao Group Medical Polymer Co., Ltd., 2008) has gone furthest, with 78 descendants of its own.
  • 2 other devices also cite its predicate K024052.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.

Indications for use as stated in the FDA summary.

Also cleared against K024052

2 other devices cite the same predicate.

  • K111091Merit Medical 20 ML SyringeMerit Medical Systems, Inc. · 2011
  • K070856Icu Medical Single-Use SyringeIcu Medical, Inc. · 2007

More from Welmed, Inc.

3 FDA decisions under this applicant name. See the company

  • K070432General Surgery DrapesWelmed, Inc. · 2007
  • K070431Welmed, Inc. Surgical GownsWelmed, Inc. · 2007

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/K070936 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070936: Welmed Hypodermic Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070936

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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