CuffTrek— 510(k) K242642

Substantially Equivalent

Shanghai Longmann Tech Co., Ltd.

FDA 510(k) clearance K242642 for CuffTrek, Substantially Equivalent on 2025-03-07. Applicant: Shanghai Longmann Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Longmann Tech Co., Ltd.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2024-09-03
Decision date: 2025-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSK

K261499 — TrachFlush2026-08-13
K243562 — CuffGuard2025-08-12
K220854 — TrachCuff Cuff Controller2023-04-14
K221477 — AG100s2022-12-29
K202874 — Puritan Bennett Cuff Pressure Manager2021-01-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.