Product code PBZ— General Hospital

SurgiCount+ System

Classification name: Image Processing Device For Estimation Of External Blood Loss
Device class: Class 2
Regulation: 21 CFR 880.2750
Advisory panel: General Hospital
Total cleared: 6
First cleared: 2014-05-09
Most recent: 2026-03-16

FDA classification definition

“An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.”
— U.S. Food and Drug Administration, device classification record for product code PBZ under 21 CFR 880.2750, via openFDA

Market context for product code PBZ

FDA has cleared 6 devices under product code PBZ between 2014 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20261 clearance
20241 clearance
20171 clearance
20161 clearance
20151 clearance
20141 clearance

Top applicants under product code PBZ

Gauss Surgical, Inc.,4 clearances
Stryker Instruments2 clearances

Recent clearances under product code PBZ

K252282 — SurgiCount+ SystemStryker Instruments·2026-03-16
K232250 — SurgiCount+ SystemStryker Instruments·2024-01-11
K163507 — Triton Sponge SystemGauss Surgical, Inc.,·2017-04-25
K160338 — Triton SystemGauss Surgical, Inc.,·2016-08-05
K142801 — Triton Canister SystemGauss Surgical, Inc.,·2015-03-12
DEN130015 — PIXEL 3 SYSTEMGauss Surgical, Inc.,·2014-05-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.