510(k) · Cleared
ClearedProfoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CMT Health PTE., Ltd. · FMF Syringe, Piston
Cleared on Feb 23, 2026 as substantially equivalent to K223453 (Promisemed Hangzhou Meditech Co., Ltd., 2023) and 1 other predicate after a 154-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Feb 23, 2026
- Review
- 154 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931367 (1993). 24 ancestors in all, the oldest K822083 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 5 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 4 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 3 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 2 generations backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- 1 generation backK223453 Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. · 2023
- This deviceK253068 Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin…CMT Health PTE., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −5 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −4 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −3 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −2 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| −1 | K223453 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
| 0 (this device) | K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 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 | 2 | 0 |
| 2007 | 2 | 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 16.2 · 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? (2)
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 |
|---|---|---|---|
| * | K223453 | Insulin SyringeSummary page 6…1 principle of a piston syringe. 3. Predicate Device Identification Insulin Syringes K223453 - Insulin Syringe Safelock Disposable Insulin Syringe K061492 - Kendall Monoject Magellan Insulin Safety Syringe 4. Non-Clinical… | 2023 |
| * | K061492 | Monoject Magellan Insulin and Tuberculin Safety SyringeSummary page 6…principle of a piston syringe. 3. Predicate Device Identification Insulin Syringes K223453 - Insulin Syringe Safelock Disposable Insulin Syringe K061492 - Kendall Monoject Magellan Insulin Safety Syringe 4. Non-Clinical Test Conclusion Non-clinical verification of the Profoject™ I… | 2006 |
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?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K223453.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Profoject™ Insulin Syringes (Model A):
The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Profoject™ Insulin Syringes (Model B):
The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Profoject™ Safelock Disposable Insulin Syringe
The device is intended for the delivery of U-40 or U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253068: Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253068
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