General Hospital · 510(k) · 2016
Triton System
GAUSS SURGICAL INC.. Cleared by FDA on 5 August 2016 under submission K160338, product code PBZ (image processing device for estimation of external blood loss). What FDA's record says, in FDA's words.
Device record · K160338
- Device. Triton SystemDEVICE
- Company. GAUSS SURGICAL INC.COMPANY
- Decision. 5 August 2016, 510(k), substantially equivalent (traditional review); received 8 February 2016DECISION
- Panel. General HospitalPANEL
- Product code. PBZ, Image Processing Device For Estimation Of External Blood LossCODE
- Regulation. 21 CFR 880.2750, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Triton System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with the Triton System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user‐entered patient serum Hb value. The validated surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time. The Triton System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 268 reports filed against devices carrying product code PBZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
22 July 2026 · Malfunction · SC+ AI SOFTWARE · STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP · report 3015967359-2026-99394
22 April 2026 · Malfunction · SURGICAL TABLET 3.0 · STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP · report 3015967359-2026-99221
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) ¿ (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: LOW READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
22 April 2026 · Malfunction · TRITON AI SOFTWARE · STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP · report 3015967359-2026-99319
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: LOW READINGS. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
23 January 2026 · Malfunction · TRITON AI SOFTWARE · STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP · report 3015967359-2026-99040
NO CHANGE.
23 January 2026 · Malfunction · SC+ AI SOFTWARE · STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP · report 3015967359-2026-99121
NO CHANGE.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PBZ, in General Hospital, or cleared in 2016. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.