510(k) Report

510(k) · Cleared

Cleared

Forsure Disposable Syringe with Needle, Model 1CC, 3C, 5CC, 10CC, 20CC, 50CC

K062753510(k) AbbreviatedCleared Feb 8, 2007147-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

Surgimed, Inc. · FMF Syringe, Piston

Cleared on Feb 8, 2007 as substantially equivalent to K980580 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) after a 147-day review. Its family tree reaches back 1 generation to 1998.

Decided
Feb 8, 2007
Review
147 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K980580 (1998). No later device cites it as a predicate yet.

K980580 · Becton Dickinson Syringes · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19981996199820002002200420062008
K980580 · Becton Dickinson Syringes · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19980
  1. Root · 1 generation backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
  2. This deviceK062753 Forsure Disposable Syringe with Needle, Model 1CC, 3C, 5CC, 10CC…Surgimed, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K980580Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic1998—
0 (this device)K062753Forsure Disposable Syringe with Needle, Model 1CC, 3C, 5CC, 10CC, 20CC, 50CCSurgimed, Inc.2007—
FIG. 1 — Lineage of K062753, 1998–2007Source: 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
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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
*K980580Becton Dickinson Syringes
Summary page 1
…2 Product Code: FMF Regulation Number: 21 CFR 880. 5860 Predicative Device: Becton Dickinson® Disposable Syringe (K980580) Modifications: There are no modifications to the device design that affect safety and eff…
Bd Becton Dickinson Vacutainer Systems Preanalytic1998—

Also cleared against K980580: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.
  • 8 other devices also cite its predicate K980580.

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?

To inject fluids into or withdraw fluids from the body.

For Injection of Insulin U-100 only.

Indications for use as stated in the FDA summary.

Also cleared against K980580

8 other devices cite the same predicate.

  • K203453BD Hypodermic SyringeBecton, Dickinson and Company · 2021
  • K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
  • K110112Cell-Tissue Converter (CTC) Syringe with NeedleRongshan LI · 2011
  • K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008
  • K050134Icc Insulin Safepro Safety SyringeFormosa Medical Devices, Inc. · 2005
  • K024052Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003

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/K062753 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062753: Forsure Disposable Syringe with Needle, Model 1CC, 3C, 5CC, 10CC, 20CC, 50CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062753

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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