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Cuffix 01

by Biovo Technologies, Ltd.

Cuffix 01, an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by Biovo Technologies, Ltd., was cleared under FDA 510(k) K192611 on 13 Aug 2020 and listed in FDA GUDID on 24 Dec 2020 (UDI-DI 07290017345017); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K192611

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290017345017 UDI-DI Date24 Dec 2020ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192611 Date13 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192611 decided 13 Aug 2020 Active
  • FDA GUDID UDI-DI 07290017345017 listed 24 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192611
  2. Listed FDA GUDID 07290017345017

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cuffix
Generic name
Endotracheal tube cuff inflator
Model / reference
01
Primary DI / UDI-DI
07290017345017
510(k) Number
FDA product code
BSK
GMDN term
Endotracheal tube cuff inflator
Device class
Class II
Regulation number
868.5750
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K192611)

Similar devices

Other devices filed under FDA product code BSK (Cuff, Tracheal Tube, Inflatable).

Other devices from Biovo Technologies, Ltd.

  • Cuffix 02

    Class II

  • Cuffix

    Class II

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)