510(k) · Cleared
ClearedProfoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle
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 Jun 12, 2026 as substantially equivalent to K212920 (Shandong Weigao Group Medical Polymer Co., Ltd., 2022) and 1 other predicate after a 115-day review. Its family tree reaches back 8 generations to 1977.
- Decided
- Jun 12, 2026
- Review
- 115 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K771205 (1977). 31 ancestors in all, the oldest K771203 (1977). No later device cites it as a predicate yet.
- Root · 8 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 7 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 6 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 5 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 4 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 3 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 2 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 1 generation backK212920 Sterile Safety Syringe with Needle for Single Use, Sterile Safety…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022
- This deviceK260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle…CMT Health PTE., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −7 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −6 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −5 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −4 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −3 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −2 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −1 | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic… | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022 | — |
| 0 (this device) | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Summary page 6…I Regulation Number: 21 CFR 880.5570 5. Identification of Predicate Device 5.1 Safety Needle and Syringe with Safety Needle 510(k) Number: K212920 Trade Name: Sterile Safety Syringe with Needle for Single Use (Used as predicate device)… | 2022 |
| * | K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSummary page 6…I Regulation Number: 21 CFR 880.5860 21 CFR 880.5570 5.2 Low Dead Space Syringe with Safety Needle 510(k) Number: K232943 Trade Name: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe Common Name:… | 2024 |
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 49 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 6 of the 31 ancestors have a recall of any class.
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?
The Profoject™ Safety Needle is intended to be used with a Luer slip or Luer lock syringe for withdrawal and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The Profoject™ Syringe with Safety Needle is intended for use in the withdrawal and injection of fluids for medical…
Read the full statement (159 words)
The Profoject™ Safety Needle is intended to be used with a Luer slip or Luer lock syringe for withdrawal and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The Profoject™ Syringe with Safety Needle is intended for use in the withdrawal and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The Profoject™ Low Dead Space Syringe with Safety Needle is intended for use in the withdrawal and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260514: Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260514
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026