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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K252282

510(k) cleared

SurgiCount+ System

Stryker Instruments · Mar 16, 2026 · K252282

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: K261544 (Hydro Irrigation System), K253679 (Hydro Irrigation System), K251971 (RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer), K250483 (PhotonBlade 3; PhotonBlade 3 Smoke Evacuation).

Questions & Answers

What did FDA clear under K252282?

K252282 is the FDA 510(k) for SurgiCount+ System, submitted by Stryker Instruments. FDA's decision date was Mar 16, 2026, under product code PBZ (Image Processing Device For Estimation Of External Blood Loss).

Who makes the SurgiCount+ System?

Stryker Instruments, based in Portage, MI, is the applicant of record for K252282.

How long did the K252282 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Mar 16, 2026, 237 days later.

← All decisions in March 2026

Sources