FDA product code PBZ: Image Processing Device For Estimation Of External Blood Loss
PBZ is the FDA product code for image processing device for estimation of external blood loss. It is a Class II device, regulated under 21 CFR 880.2750 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under PBZ, 2 in the last five years, from 2 different applicants. The average 510(k) review took 176 days (median 167); 202 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 4 recalls for PBZ devices, 3 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Image Processing Device For Estimation Of External Blood Loss |
| Device class | Class II |
| Regulation | 21 CFR 880.2750 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PBZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 132 |
| 2024 | 1 | 167 |
| 2026 | 1 | 237 |
Compare with all 510(k) review times · Search every PBZ clearance
Top PBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gauss Surgical, Inc., | 3 | 2017-04-25 |
| Stryker Instruments | 2 | 2026-03-16 |
Most recent PBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252282 | Stryker Instruments | SurgiCount+ System | 2026-03-16 | 237 |
| K232250 | Stryker Instruments | SurgiCount+ System | 2024-01-11 | 167 |
| K163507 | Gauss Surgical, Inc., | Triton Sponge System | 2017-04-25 | 132 |
| K160338 | Gauss Surgical, Inc., | Triton System | 2016-08-05 | 179 |
| K142801 | Gauss Surgical, Inc., | Triton Canister System | 2015-03-12 | 164 |
Recalls for PBZ devices
4 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-01-25.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 3 |
Frequently asked questions
What is FDA product code PBZ?
PBZ is the FDA product code for image processing device for estimation of external blood loss. It is a Class II device, regulated under 21 CFR 880.2750 and reviewed by the General and Plastic Surgery panel.
What device class is PBZ?
Class II, regulation 21 CFR 880.2750. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBZ?
Across 5 cleared submissions the average was 176 days from receipt to decision (median 167).
Which companies have the most PBZ clearances?
Gauss Surgical, Inc., (3); Stryker Instruments (2).
Have PBZ devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2023-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code PBZ
- Run a recall and safety report across every PBZ manufacturer
- Watch product code PBZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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