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Portex 10050-05S

by ICU Medical, Inc.

Portex 10050-05S is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K790312 on 21 Feb 1979 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10610674804056), active as of 23 Oct 2026. 6 FDA recalls are 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

1 ongoing

This device is named in the recall

Documents

510(k) K790312

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 Number10610674804056 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK790312 Date21 Feb 1979DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K790312 decided 21 Feb 1979 Active
  • FDA GUDID UDI-DI 10610674804056 listed 1 Sep 2015 Listed

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-1289-2025 FDA Class I initiated 13 Feb 2025

    Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

  • 4 recalls, same reason

    • Terminated Z-2538-2014 FDA Class I initiated 7 Jul 2014
    • Terminated Z-2537-2014 FDA Class I initiated 7 Jul 2014
    • Terminated Z-2539-2014 FDA Class I initiated 7 Jul 2014
    • Terminated Z-2536-2014 FDA Class I initiated 7 Jul 2014

    The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

    • Terminated Z-1641-2014 FDA Class I initiated 10 Apr 2014

    One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

Timeline

8 dated events

  1. Cleared FDA 510(k) K790312
  2. Recall initiated FDA recalls Z-1641-2014
  3. Recall initiated FDA recalls Z-2538-2014
  4. Recall initiated FDA recalls Z-2537-2014
  5. Recall initiated FDA recalls Z-2539-2014
  6. Recall initiated FDA recalls Z-2536-2014
  7. Listed FDA GUDID 10610674804056
  8. Recall initiated FDA recalls Z-1289-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Portex
Generic name
Breathing circuit catheter mount, single-use
Model / reference
10050-05S
Primary DI / UDI-DI
10610674804056
510(k) Number
FDA product code
BTR
GMDN term
Breathing circuit catheter mount, single-use
Device class
Class II
Regulation number
868.5730
GUDID distribution status
In Commercial Distribution

Related devices

Category: Breathing circuit catheter mount, single-use

Cleared under the same submission (K790312)

and 8 more cleared under K790312

Similar devices in this category

Other devices filed under Breathing circuit catheter mount, single-use.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)