510(k) · Cleared
ClearedGreenmedi Safety Filter Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sang-A Frontec Co., Ltd. · MEG Syringe, Antistick
Cleared on Jan 28, 2019 as substantially equivalent to K092430 (Inviro Medical Devices, Inc., 2009) after a 417-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Jan 28, 2019
- Review
- 417 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941450 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK941450 Inviro SyringeDr. F. Ross Sharp, Ltd. · 1994
- 2 generations backK032780 Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003
- 1 generation backK092430 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock…Inviro Medical Devices, Inc. · 2009
- This deviceK173743 Greenmedi Safety Filter SyringeSang-A Frontec Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK212635 SofjecHwajin Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK241856 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK253112 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See all- K212635SofjecHwajin Medical Co., Ltd. · 2023 · cites it directly2descendants
- K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2024 · 2 generations on1descendant
- K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941450 | Inviro Syringe | Dr. F. Ross Sharp, Ltd. | 1994 | — |
| −2 | K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC | Inviro Medical | 2003 | — |
| −1 | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML… | Inviro Medical Devices, Inc. | 2009 | — |
| 0 (this device) | K173743 | Greenmedi Safety Filter Syringe | Sang-A Frontec Co., Ltd. | 2019 | — |
| +1 | K212635 | Sofjec | Hwajin Medical Co., Ltd. | 2023 | — |
| +2 | K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without… | Hlb Lifescience Co., Ltd. | 2024 | — |
| +3 | K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without… | Hlb Lifescience Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…Summary page 4…ode: MEG Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital 4. Predicate Device: 510k #: K092430 Manufacturer: Inviro Medical, Inc. Device Name: InviroSnap Safety Syringe 5. Device Description… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212635 | Sofjec | 2023 | 2 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K212635 (Hwajin Medical Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K092430.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Greenmedi safety filter syringe is intended to inject the drug solutions into the human body. It is designed to prevent needle stick injuries. The 0.5um filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173743: Greenmedi Safety Filter Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173743
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