FDA cleared the SurgiCount+ System from Stryker Instruments on Mar 16, 2026 under K252282, a traditional 510(k). The device falls under product code PBZ, Image Processing Device For Estimation Of External Blood Loss, regulated at 21 CFR 880.2750 as a Class 2 device. The review panel was General Hospital.
FDA logged the submission as received on Jul 22, 2025. The decision came 237 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Stryker Instruments has 4 other decisions in the tracker over the last 12 months: K262244 (Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)), K261959 (Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)), K261544 (Hydro Irrigation System), K253679 (Hydro Irrigation System).