PBZ
6 FDA 510(k) clearances · Product code
179 daysmedian time to decision
459 days90th percentile
6clearances measured
FDA profile
- Official device name
- Image Processing Device For Estimation Of External Blood Loss
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2750
- Medical specialty
- General Hospital
- FDA 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.
- Adverse events (MAUDE)
- 2023: 246
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SurgiCount+ System (K252282) | Stryker Instruments | 2026-03-16 |
| SurgiCount+ System (K232250) | Stryker Instruments | 2024-01-11 |
| Triton Sponge System (K163507) | Gauss Surgical, Inc., | 2017-04-25 |
| Triton System (K160338) | Gauss Surgical, Inc., | 2016-08-05 |
| Triton Canister System (K142801) | Gauss Surgical, Inc., | 2015-03-12 |
| PIXEL 3 SYSTEM (DEN130015) | Gauss Surgical, Inc., | 2014-05-09 |
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Every clearance here is in the API, with alerts when new ones post.