510(k) · Cleared
Cleared1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unilife Medical Solutions Limited · MEG Syringe, Antistick
Cleared on Oct 21, 2008 as substantially equivalent to K050134 (Formosa Medical Devices, Inc., 2005) and 1 other predicate after a 204-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Oct 21, 2008
- Review
- 204 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K980069 (1998). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- 1 generation backK023752 BD Integra SyringeBd · 2003 · Recalled
- This deviceK080877 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited · 2008
- Descendant · cites it directly · 1 of its ownK093400 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited · 2010
- Descendant · 2 generations on · 0 of its ownK100998 1ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| −1 | K023752 | BD Integra Syringe | Bd | 2003 | 2 |
| 0 (this device) | K080877 | 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2 | Unilife Medical Solutions Limited | 2008 | — |
| +1 | K093400 | 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2 | Unilife Medical Solutions Limited | 2010 | — |
| +2 | K100998 | 1ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1 | Unilife Medical Solutions Limited | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
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 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050134 | Icc Insulin Safepro Safety SyringeSummary page 2…UnlLIF=O~ Substantial The lmL Unitract® Insulin Syringe has identical indications for Equivalence: use and similar features to the cited predicate # K050134 which is to infuse insulin subcutaneously; whilst incorporating a sharps injury preventio… | 2005 |
| * | K023752 | BD Integra SyringeSummary page 1…, Piston; 21 CFR 880.5860; FMF; Class 11 Predicate Devices: 1cc Insulin SafeProg® Safety Syringe (KO501 34) BID Integra l mL Syringe (K023752) Device Description: The lmL Unitract® Insulin Syringe is a sterile, fixed needle, single use, i… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093400 | 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2 | 2010 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K093400 (Unilife Medical Solutions Limited, 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K050134.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The syringe as supplied is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), intended to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080877 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080877: 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080877
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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