510(k) Report

510(k) · Cleared

Cleared

Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC

K081547510(k) TraditionalCleared Sep 8, 200898-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

Bio-Med USA, Inc. · FMF Syringe, Piston

Cleared on Sep 8, 2008 as substantially equivalent to K024112 (Becton, Dickinson & CO, 2003) and 8 other predicates after a 98-day review. Its family tree reaches back 4 generations to 1994.

Decided
Sep 8, 2008
Review
98 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
9

Its longest line of descent runs back 4 generations to K941657 (1994). 15 ancestors in all, the oldest K822083 (1982). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor1985: 1 other ancestor1982: 1 other ancestor1992: 1 other ancestor2003: 1 other ancestor2000: 1 other ancestor1994: 1 other ancestorK941657 · BD Micro Fine, Ultra Fine, and Allergy Syringe · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994K024112 · BD Insulin Syringe · Becton, Dickinson & CO · 2003 · recalledK062702 · Ulticare Disposable Syringes and Needles · Ultimed, Inc. · 2006 · recalledK070917 · Feel-Ject Insulin Syringe · Feel Tech · 2007 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 1 other ancestor K070917 · Feel-Ject Insulin Syringe · Feel Tech · 2007 · recalledK062702 · Ulticare Disposable Syringes and Needles · Ultimed, Inc. · 2006 · recalledK024112 · BD Insulin Syringe · Becton, Dickinson & CO · 2003 · recalledK941657 · BD Micro Fine, Ultra Fine, and Allergy Syringe · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19940
  1. Root · 4 generations backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
  2. 3 generations backK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003 · Recalled
  3. 2 generations backK062702 Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · Recalled
  4. 1 generation backK070917 Feel-Ject Insulin SyringeFeel Tech · 2007 · Recalled
  5. This deviceK081547 Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K941657BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic1994—
−3K024112BD Insulin SyringeBecton, Dickinson & CO20033
−2K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc.20061
−1K070917Feel-Ject Insulin SyringeFeel Tech20071
0 (this device)K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198510
199210
199410
199610
199810
199920
200010
200310
200710
FIG. 1 — Lineage of K081547, 1994–2008Source: 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? (9)

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
*K024112BD Insulin Syringe
Summary page 1
…aterial to other several Insulin Syringe previously cleared by the 510(K) process as listed below 510(K) Brand Company K024112, K980580 Ultra Fine II Becton Dickinson K991758, K851090 Monoject Kendall Monoject K992…
Becton, Dickinson & CO20033
*K980580Becton Dickinson Syringes
Summary page 1
…o other several Insulin Syringe previously cleared by the 510(K) process as listed below 510(K) Brand Company K024112, K980580 Ultra Fine II Becton Dickinson K991758, K851090 Monoject Kendall Monoject K992802…
Bd Becton Dickinson Vacutainer Systems Preanalytic1998—
*K991758Monoject Insulin Syringe
Summary page 1
…y the 510(K) process as listed below 510(K) Brand Company K024112, K980580 Ultra Fine II Becton Dickinson K991758, K851090 Monoject Kendall Monoject K992802 Terumo Insulin Terumo Inc. K070917…
The Kendal Co.1999—
*K851090Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee
Summary page 1
…(K) process as listed below 510(K) Brand Company K024112, K980580 Ultra Fine II Becton Dickinson K991758, K851090 Monoject Kendall Monoject K992802 Terumo Insulin Terumo Inc. K070917…
Sherwood Medical Co.19851
*K992802Terumo U-100 Insulin Syringe
Summary page 1
…Brand Company K024112, K980580 Ultra Fine II Becton Dickinson K991758, K851090 Monoject Kendall Monoject K992802 Terumo Insulin Terumo Inc. K070917 Feel-Ject Insulin Feel-Tech K063348…
Terumo Medical Corp.1999—
*K070917Feel-Ject Insulin Syringe
Summary page 1
…Ultra Fine II Becton Dickinson K991758, K851090 Monoject Kendall Monoject K992802 Terumo Insulin Terumo Inc. K070917 Feel-Ject Insulin Feel-Tech K063348 Top Fine Insulin Syringe, Dae Jin…
Feel Tech20071
*K063348Top Fine Insulin Syringe
Summary page 1
…Monoject Kendall Monoject K992802 Terumo Insulin Terumo Inc. K070917 Feel-Ject Insulin Feel-Tech K063348 Top Fine Insulin Syringe, Dae Jin I2..…
Daejin Tech Medical Manufacturing Co., Ltd.2007—
*K822083U-100 Insulin Syringe
Summary page 3
…be Biocompatible. Conclusion The "Bio-Med® Soft" Insulin Syringe submitted in this Pre-market notification is substantially equivalent to the Terumo Insulin Syringe K 822083, K992802, Becton Dickinson Ultra Fine II K955235, Feel-Ject Insulin Syringe K070917 in respect to intended use, design, used ma…
Terumo Medical Corp.1982—
*K955235B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe
Summary page 3
…" Insulin Syringe submitted in this Pre-market notification is substantially equivalent to the Terumo Insulin Syringe K 822083, K992802, Becton Dickinson Ultra Fine II K955235, Feel-Ject Insulin Syringe K070917 in respect to intended use, design, used material, producing process, Technology / Principle…
Bd Becton Dickinson Vacutainer Systems Preanalytic19961

Also cleared against K024112: 10 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?

  • The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
  • 6 of the 15 ancestors have a recall of any class.
  • 10 other devices also cite its predicate K024112.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

Single use, sterile, intended use for the subcutaneous injection of U-100 Insulin only.

Indications for use as stated in the FDA summary.

Also cleared against K024112

10 other devices cite the same predicate.

  • K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD…Becton Dickinson & Company · 2017
  • K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD…Becton, Dickinson and Company · 2016
  • K151870BD U-500 Insulin SyringeBecton, Dickinson and Company · 2016
  • K110882Imc Insulin SyringeInternational Medsurg Connection · 2011
  • K091167Shina Insulin Syringe-Including Accu-Sure Insulin SyringesShina Corp. · 2009
  • K071459B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc. · 20072 recalls

More from Bio-Med USA, Inc.

10 FDA decisions under this applicant name. See the company

  • K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc. · 2022
  • K212082PicoreBio-Med USA, Inc. · 2021
  • K182270Cellene CO2 Laser SystemBio-Med USA, Inc. · 2018
  • K163638Dental 5 Multi Diode laserBio-Med USA, Inc. · 2017
  • K140837Lucid LYBio-Med USA, Inc. · 2014

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/K081547 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081547: Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081547

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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