510(k) · Cleared
ClearedInsulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · FMF Syringe, Piston
Cleared on Mar 2, 2023 as substantially equivalent to K110421 (Wenzhou Wuzhou Import & Export Co., Ltd., 2011) after a 106-day review. Its family tree reaches back 5 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 2, 2023
- Review
- 106 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931367 (1993). 21 ancestors in all, the oldest K822083 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 4 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 3 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 2 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 1 generation backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- This deviceK223453 Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253068 Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin…CMT Health PTE., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK233794 Insulin SyringeSpm Medicare Pvt., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −4 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −3 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −2 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −1 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| 0 (this device) | K223453 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
| +1 | K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026 | — |
| +1 | K233794 | Insulin Syringe | Spm Medicare Pvt., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | K110421 | Disposable Insulin SyringeSummary page 4…name: Piston syringe Regulation Number: 880.5680 Device Class: Class II Product Code: FMF 4. Identification of Predicate Device K110421; Disposable Insulin Syringe 5. Description of the Device The proposed device Insulin Syringe, a sterile device cons… | 2011 |
What descends from it? (2)
2 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?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K253068 (CMT Health PTE., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110421.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223453: Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223453
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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