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Bivona FT26JN60NSA203N

by ICU Medical, Inc.

Bivona FT26JN60NSA203N is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K923878 on 29 Dec 1992 and listed in FDA GUDID since 28 Oct 2026 (UDI-DI 10887709207742), active as of 9 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K923878

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10887709207742 UDI-DI Date28 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK923878 Date29 Dec 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K923878 decided 29 Dec 1992 Active
  • FDA GUDID UDI-DI 10887709207742 listed 28 Oct 2026 Listed

Recalls

1 recall · FDA

    • Terminated Z-0260-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006

    Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

Timeline

3 dated events

  1. Cleared FDA 510(k) K923878
  2. Recall initiated FDA recalls Z-0260-2007
  3. Listed FDA GUDID 10887709207742

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bivona
Generic name
Tracheostomy tube, reinforced, non-customized, reusable
Model / reference
FT26JN60NSA203N
Primary DI / UDI-DI
10887709207742
510(k) Number
FDA product code
JOH
GMDN term
Tracheostomy tube, reinforced, non-customized, reusable
Device class
Class II
Regulation number
868.5800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K923878)

and 8 more cleared under K923878

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

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