510(k) · Cleared
ClearedInviro Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. F. Ross Sharp, Ltd. · MEG Syringe, Antistick
Cleared on Dec 12, 1994 after a 263-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Dec 12, 1994
- Review
- 263 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 3 citing it directly.
- This deviceK941450 Inviro SyringeDr. F. Ross Sharp, Ltd. · 1994
- Descendant · cites it directly · 10 of its ownK040036 Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004
- Descendant · cites it directly · 10 of its ownK032780 Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003
- Descendant · 2 generations on · 9 of its ownK092430 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock…Inviro Medical Devices, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- Descendant · 3 generations on · 5 of its ownK152808 U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004 · cites it directly10descendants
- K032780Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003 · cites it directly10descendants
- K0924301 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…Inviro Medical Devices, Inc. · 2009 · 2 generations on9descendants
- K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005 · 2 generations on8descendants
- K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941450 | Inviro Syringe | Dr. F. Ross Sharp, Ltd. | 1994 | — |
| +1 | K040036 | Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905 | Inviro Medical | 2004 | — |
| +1 | K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC | Inviro Medical | 2003 | — |
| +2 | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML… | Inviro Medical Devices, Inc. | 2009 | — |
| +2 | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| +3 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040036 (Inviro Medical, 2004) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K941450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941450: Inviro Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941450
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026