510(k) · Cleared
ClearedInvirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and 130024
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 Apr 23, 2007 as substantially equivalent to K941450 (Dr. F. Ross Sharp, Ltd., 1994) after a 91-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 23, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941450 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941450 Inviro SyringeDr. F. Ross Sharp, Ltd. · 1994
- This deviceK070203 Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080…Inviro Medical Devices, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941450 | Inviro Syringe | Dr. F. Ross Sharp, Ltd. | 1994 | — |
| 0 (this device) | K070203 | Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022… | Inviro Medical Devices, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K941450 | Inviro SyringeSummary page 1…880.5860 Reason for 510(k): Special 510(k) C. Predicate Device: INVIRO 6 cc Syringe Predicate 5 10(k) #: K941450 Predicate product code: MEG D. Device Description The Inviro Medical InviroSnap Safety Sy… | 1994 |
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.
- 2 other devices also cite its predicate K941450.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Safety Syringe is used to inject fluids into, or withdraw fluids from, 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/K070203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070203: Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and 130024.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070203
Report an extraction error
Are you the manufacturer?
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