510(k) · Cleared
ClearedInvirosnap 50 and 100 Unit Insulin Safety Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inviro Medical Devices, Inc. · MEG Syringe, Antistick
Cleared on Sep 4, 2009 as substantially equivalent to K040036 (Inviro Medical, 2004) after a 28-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 4, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941657 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 2 generations backK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003 · Recalled
- 1 generation backK040036 Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004
- This deviceK092413 Invirosnap 50 and 100 Unit Insulin Safety SyringesInviro Medical Devices, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941657 | BD Micro Fine, Ultra Fine, and Allergy Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| −2 | K024112 | BD Insulin Syringe | Becton, Dickinson & CO | 2003 | 3 |
| −1 | K040036 | Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905 | Inviro Medical | 2004 | — |
| 0 (this device) | K092413 | Invirosnap 50 and 100 Unit Insulin Safety Syringes | Inviro Medical Devices, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040036 | Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Summary page 1…) C. Predicate Device: InviroSnap 100 unit Insulin Safety Syringe Predicate 510(k) #: K040036 Predicate product code: MEG D. Device Description The Inviro Medical InviroSnap 50 and 1… | 2004 |
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 15 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K040036.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 InviroSnap 50 and 100 unit Insulin Safety Syringe is used to inject insulin into the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092413 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092413: Invirosnap 50 and 100 Unit Insulin Safety Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092413
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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