510(k) · Cleared
Cleared1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock 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 K032780 (Inviro Medical, 2003) after a 28-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Sep 4, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941450 (1994). 9 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK941450 Inviro SyringeDr. F. Ross Sharp, Ltd. · 1994
- 1 generation backK032780 Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003
- This deviceK092430 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock…Inviro Medical Devices, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK173743 Greenmedi Safety Filter SyringeSang-A Frontec Co., Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK212635 SofjecHwajin Medical Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK241856 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK253112 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK212226 DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K173743Greenmedi Safety Filter SyringeSang-A Frontec Co., Ltd. · 2019 · cites it directly3descendants
- K212635SofjecHwajin Medical Co., Ltd. · 2023 · 2 generations on2descendants
- K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2024 · 3 generations on1descendant
- K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2026 · 4 generations on0descendants
- K212226DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941450 | Inviro Syringe | Dr. F. Ross Sharp, Ltd. | 1994 | — |
| −1 | K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC | Inviro Medical | 2003 | — |
| 0 (this device) | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML… | Inviro Medical Devices, Inc. | 2009 | — |
| +1 | K173743 | Greenmedi Safety Filter Syringe | Sang-A Frontec Co., Ltd. | 2019 | — |
| +2 | K212635 | Sofjec | Hwajin Medical Co., Ltd. | 2023 | — |
| +3 | K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without… | Hlb Lifescience Co., Ltd. | 2024 | — |
| +4 | K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without… | Hlb Lifescience Co., Ltd. | 2026 | — |
| +1 | K212226 | DR Safety Syringe, Sterile Hypodermic needle for Single use | Zhuhai DR Medical Instruments Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCSummary page 1…C. Predicate Device: InviroSnap 1, 3, 5 and 10 ml Safety Syringe Predicate 5 10(k) #: K032780 Predicate product code: MEG D. Device Description The Inviro Medical InviroSnap Safety S… | 2003 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173743 | Greenmedi Safety Filter Syringe | 2019 | 3 |
| K212226 | DR Safety Syringe, Sterile Hypodermic needle for Single use | 2021 | 0 |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | 2016 | 0 |
| K143070 | Disposable Safety Self-destructive Syringes, 5 ML | 2015 | 0 |
| K121637 | Auto-Disable Sterile Safty Syring for Single Use | 2012 | 0 |
| K101560 | Medline Retractable Safety Syringe | 2011 | 0 |
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 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173743 (Sang-A Frontec Co., Ltd., 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K032780.
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 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/K092430 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092430: 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock 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/K092430
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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