Triton Canister System

510(k) K142801

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK142801	Date12 Mar 2015Cleared	StatusActive

4 recalls · 3 ongoing · FDA

3 recalls, same reason
- Ongoing Z-1184-2023 FDA Class II initiated 25 Jan 2023
- Ongoing Z-1186-2023 FDA Class II initiated 25 Jan 2023
- Ongoing Z-1185-2023 FDA Class II initiated 25 Jan 2023
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
- Terminated Z-1402-2022 FDA Class II initiated 22 Jan 2020
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.

1 jurisdiction

United States — FDA 510(k) Active

510(k)