Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.
Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.: 510(k) cleared for CMT Health PTE., Ltd. Its amount of 87 is below the median of 138 (27th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 87 · 27th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related SG FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262215 |
| Device | Profoject Safety Sliding Blood Collection Set |
| Applicant | CMT Health PTE., Ltd. |
| Specialty / panel | Clinical Chemistry |
| Product code | JKA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-30 |
| Decision date | 2026-09-25 |
| Review time (days) | 87 |
| Third-party review | No |
| Applicant location | Singapore, SG |
| amount percentile | 27th of 414 (median 138, 0.6x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-25
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd. and 4 SG peers
- SG FDAPulse records like this one: 4
- Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.'s amount: 27th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every SG peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 87-day review: this device is a strong predicate for similar products.
- Posted 41 days ago.
What is the FDAPulse record for Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.?
Profoject Safety Sliding Blood Collection Set (K262215) by CMT Health PTE., Ltd. was cleared on 2026-09-25 after 87 days of review.
How does Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd. compare to other FDAPulse records?
Its amount of 87 is below the median (27th percentile); smaller records often move faster and face less competition. It is 41 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Profoject Safety Sliding Blood Collection Set (K262215) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Profoject Safety Sliding Blood Collection Set (K262215) | SG | 2026-09-25 |
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| Mint ACE Pump (K260001) | CA | 2026-09-11 |
Related records
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