K250907 is an FDA 510(k) clearance for the Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Sol-Millennium Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on April 30, 2025, 35 days after receiving the submission on March 26, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K250907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2025 |
| Decision Date | April 30, 2025 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |