CuffTrek

FDA 510(k) K242642 · Shanghai Longmann Tech Co., Ltd.

Substantially Equivalent

510(k) numberK242642

Submission

Device name
CuffTrek
Applicant
Shanghai Longmann Tech Co., Ltd.
Shanghai, CN
Received
September 3, 2024
Decision date
March 7, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSK – Cuff, Tracheal Tube, Inflatable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5750
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BSK

510(k)DeviceApplicantDecision
K261499TrachFlushBSK · Traditional Aw Technologies Aps08/13/2026SE
K243562CuffGuardBSK · Traditional Idmed08/12/2025SE
K220854TrachCuff Cuff ControllerBSK · Traditional Aw Technologies Aps04/14/2023SE
K221477AG100sBSK · Traditional Hospitech Respiration , Ltd.12/29/2022SE
K202874Puritan Bennett Cuff Pressure ManagerBSK · Traditional Covidien, LLC01/09/2021SE
K192611CuffixBSK · Traditional Biovo Technologies , Ltd.08/13/2020SE
K191858Pylant MonitorBSK · Traditional Kal-Med, LLC02/24/2020SE
K182548Accucuff Cuff Pressure IndicatorBSK · Traditional Tianjin Medis Medical Device Co., Ltd.01/25/2019SE
K180991AG 100sBSK · Traditional Hospitech Respiration , Ltd.10/12/2018SE
K173914VORTRAN Cuff Inflator (VCI)BSK · Traditional Vortran Medical Technology 1, Inc.05/25/2018SE

Questions and answers

When was CuffTrek cleared by the FDA?

CuffTrek (K242642) received a 510(k) decision of Substantially Equivalent on March 7, 2025, 185 days after the submission was received.

What is the product code of K242642?

The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.