| K-number | K252282 |
| Device name | SurgiCount+ System |
| Applicant | Stryker Instruments |
| Product code | PBZ |
| Device class | Class II |
| Decision date | Mar 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.2750 |
The SurgiCount+ System is software that assists in estimating blood loss and managing surgical sponges and absorbent items in operating rooms and surgical centers. It incorporates three configurations: Triton AI (which estimates hemoglobin mass on used sponges using AI), SC+ Sponge Counting (which tracks RFID-tagged absorbent items), and Triton QBL (which records sponge weight to calculate fluid volume). Combined workflows allow simultaneous sponge tracking and blood loss estimation.
The subject device and predicate device (K232250) have identical technological characteristics with no changes to design, software, or fundamental scientific technology. Both function as adjunctive image processing devices for external blood loss estimation and surgical sponge management.
Not stated in this summary.
Substantial equivalence is supported because the subject device has the same design, software, and fundamental scientific technology as the predicate device. Verification and Validation testing and risk assessment leveraged from the predicate device demonstrate that the subject device is as safe and effective as the predicate device. The indications for use remain substantially the same (adjunctive technology for blood loss estimation and sponge management), with only clarification of general environments of use.
View the full FDA submission: accessdata.fda.gov