Profoject Safe Push Button Blood Collection Sets— 510(k) K262242
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K262242 for Profoject Safe Push Button Blood Collection Sets, Substantially Equivalent on 2026-10-28. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Clearance details
- Applicant
- CMT Health PTE., Ltd.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code JKA
view all- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- K252344 — BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
More clearances from CMT Health PTE., Ltd.
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.