510(k) Report

510(k) · Cleared

Cleared

Icc Insulin Safepro Safety Syringe

K050134510(k) AbbreviatedCleared Apr 5, 200574-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

Formosa Medical Devices, Inc. · MEG Syringe, Antistick

Cleared on Apr 5, 2005 as substantially equivalent to K980580 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.

Decided
Apr 5, 2005
Review
74 days
Class
Class II
Product code
MEG
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K980580 (1998). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2007: 2 descendants cleared2008: 1 descendant cleared2006: 1 descendant cleared2010: 2 descendants clearedReference device: K012726 · Prosafe Safety Syringe · Hou-Se Medical, Inc. · 2001K980580 · Becton Dickinson Syringes · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant 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 deviceK050134 Icc Insulin Safepro Safety SyringeFormosa Medical Devices, Inc. · 2005
  3. Descendant · cites it directly · 2 of its ownK080877 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited · 2008
  4. Descendant · 2 generations on · 1 of its ownK093400 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited · 2010
  5. Descendant · cites it directly · 1 of its ownK061055 Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006
  6. Descendant · 3 generations on · 0 of its ownK100998 1ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited · 2010
  7. Descendant · 2 generations on · 0 of its ownK072037 Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 12010: 2
2006high 2 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited · 2008 · cites it directly2descendants
  • K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited · 2010 · 2 generations on1descendant
  • K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006 · cites it directly1descendant
  • K1009981ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited · 2010 · 3 generations on0descendants
  • K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K980580Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic1998—
0 (this device)K050134Icc Insulin Safepro Safety SyringeFormosa Medical Devices, Inc.2005—
+1K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited2008—
+2K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited2010—
+1K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc.2006—
+3K1009981ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited2010—
+2K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200810
201020
FIG. 1 — Lineage of K050134, 1998–2010Source: 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 MEG? 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 MEG device

  1. #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 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
*K980580Becton Dickinson Syringes
Summary page 1
…MENT OF SUBSTANTIAL EQUIVALENCE The Icc Insulin SafePro* Safety Syringe is essentially equivalent to: A) B-D Conventional hypodermic and insulin syringe, K980580, and B) The Icc SafePro Safety Syringe, K022063, in design, materials, instructions for use, and product claims.…
Bd Becton Dickinson Vacutainer Systems Preanalytic1998—
*K022063Safepro Safety Syringe
Summary page 1
…SafePro* Safety Syringe is essentially equivalent to: A) B-D Conventional hypodermic and insulin syringe, K980580, and B) The Icc SafePro Safety Syringe, K022063, in design, materials, instructions for use, and product claims. Page VI…
Formosa Medical Devices, Inc.2002—
†K012726Prosafe Safety SyringeHou-Se Medical, Inc.2001—

Also cleared against K980580: 8 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited20082
K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc.20061
K062780Clickzip, Model U-100 Insulin Safety SyringeMedical Device Manufacturer (Thailand), Ltd.20070

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K080877 (Unilife Medical Solutions Limited, 2008) has gone furthest, with 2 descendants of its own.
  • 8 other devices also cite its predicate K980580.

How does its category compare?

All MEG devices

MEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEG

1in 2025

2007: 82008: 42009: 22010: 22011: 52012: 52013: 12014: 52015: 72016: 32017: 32018: 12019: 42020: 42021: 52022: 132023: 52025: 12026 (partial year): 1
2007high 13 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEG

229in 2023

2007: 100 days median2008: 145 days median2011: 113 days median2012: 109 days median2014: 153 days median2015: 253 days median2016: 179 days median2017: 130 days median2019: 249 days median2020: 296 days median2021: 152 days median2022: 216 days median2023: 229 days median
2007high 296 (2020) · low 100 (2007)2026

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

Recalls per year · MEG

1in 2024

2008: 12010: 12013: 52015: 12024: 1, 1 Class I
2007high 5 (2013) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MEG

148in 2025

2007: 212008: 202009: 262010: 342011: 342012: 222013: 272014: 362015: 512016: 942017: 1812018: 2692019: 4972020: 3532021: 5412022: 1702023: 1202024: 1122025: 148
2007high 541 (2021) · low 20 (2008)2025

MAUDE reports naming product code MEG, 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
20078100021
20084145120
20092—026
20102—134
20115113034
20125109022
20131—527
20145153036
20157253151
20163179094
201731300181
20181—0269
201942490497
202042960353
202151520541
2022132160170
202352290120
20240—1 (1)112
20251—0148
20261—0—

What is it indicated for?

The primary indicated use for the icc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid.

The secondary indicated use for the Icc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

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
  • K062753Forsure Disposable Syringe with Needle, Model 1CC, 3C, 5CC, 10CC, 20CC, 50CCSurgimed, Inc. · 2007
  • K024052Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003

More from Formosa Medical Devices, Inc.

3 FDA decisions under this applicant name. See the company

  • K031830Safepro Plus Safety SyringeFormosa Medical Devices, Inc. · 2003
  • K022063Safepro Safety SyringeFormosa Medical Devices, Inc. · 2002

Recent decisions in MEG

The MEG category page

  • K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd. · 2026
  • K250847VaporShieldVault Paragon Group, Inc. · 2025
  • K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd. · 2023
  • K231165Shina Syringe; Shina Safety SyringeShina Med Corporation · 2023
  • K231907Medline Safety Insulin and TB SyringesMedline Industries, LP · 2023

https://510kreport.com/device/K050134 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050134: Icc Insulin Safepro Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050134

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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