510(k) · Cleared
ClearedProfoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CMT Health PTE., Ltd. · QNQ Low Dead Space Piston Syringe
Cleared on Feb 19, 2026 as substantially equivalent to K242291 (Sol-Millennium Medical, Inc., 2024) and 1 other predicate after a 168-day review. Its family tree reaches back 10 generations to 1977.
- Decided
- Feb 19, 2026
- Review
- 168 days
- Class
- Class II
- Product code
- QNQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K771205 (1977). 34 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 6 generations between
- 3 generations backK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- 2 generations backK213010 FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023
- 1 generation backK231856 TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334…Medexel Co.,Ltd · 2024
- This deviceK252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe…CMT Health PTE., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 9 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 8 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 7 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 6 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 5 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 4 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 3 generations backK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- 2 generations backK213010 FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. · 2023
- 1 generation backK231856 TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334…Medexel Co.,Ltd · 2024
- This deviceK252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe…CMT Health PTE., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −9 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −8 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −7 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −6 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −5 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −4 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −3 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| −2 | K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023 | — |
| −1 | K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | 2024 | — |
| 0 (this device) | K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 QNQ? 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 QNQ device
- #1 K210443 PLPT LDV (Low Dead Volume) Sterile Syringescore 18.0 · 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 |
|---|---|---|---|
| * | K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…Summary page 7…specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G. 3. Predicate Device Identification Profoject™ Low Dead Space Syringe /Profoject™ K242291 - SOL-M Luer Lock Syringe (Low Dead Tuberculin Syringe, Space) w/o Needle, SOL-M Slip Tip Syringe… | 2024 |
| * | K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Summary page 7…dle, SOLM Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle Profoject™ Low Dead Space Syringe with K231856 - TopFine® LDS (Low Dead Space) Permanent Needle /Profoject™ Tuberculin Syringe (2 models (TS-LDS2334, TSLDS2534)) Sy… | 2024 |
| † | K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently… | 2022 |
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 8 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 34 ancestors have a recall of any class.
- 1 other device also cites its predicate K242291.
How does its category compare?
All QNQ devicesQNQ Low Dead Space Piston Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QNQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNQ
182in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QNQ
No recall names QNQ since 2007.
Adverse event reports per year · QNQ
3in 2025
MAUDE reports naming product code QNQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 182 | 0 | 0 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body. Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body. Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids…
Read the full statement (132 words)
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252814: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252814
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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