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Portex 8500

by ICU Medical, Inc.

Portex 8500 is a pulmonary resuscitator (FDA Class II; FDA product code BTM, Ventilator, emergency, manual (resuscitator)) made by ICU Medical, Inc., cleared under FDA 510(k) K014115 on 27 Feb 2002 and listed in FDA GUDID since 29 Jul 2015 (UDI-DI 10351688431219), active as of 23 Oct 2026. 3 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

None ongoing

3 closed

Documents

510(k) K014115

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 Number10351688431219 UDI-DI Date29 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK014115 Date27 Feb 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K014115 decided 27 Feb 2002 Active
  • FDA GUDID UDI-DI 10351688431219 listed 29 Jul 2015 Listed

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0808-03 FDA Unclassified (pre-2012) initiated 15 Nov 2002
    • Terminated Z-0810-03 FDA Unclassified (pre-2012) initiated 15 Nov 2002
    • Terminated Z-0809-03 FDA Unclassified (pre-2012) initiated 15 Nov 2002

    Peep valve set at the highest level and could result in patient injury

Timeline

5 dated events

  1. Cleared FDA 510(k) K014115
  2. Recall initiated FDA recalls Z-0808-03
  3. Recall initiated FDA recalls Z-0810-03
  4. Recall initiated FDA recalls Z-0809-03
  5. Listed FDA GUDID 10351688431219

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  • Withdrawn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
Pulmonary resuscitator, manual, single-use
Model / reference
8500
Primary DI / UDI-DI
10351688431219
510(k) Number
FDA product code
BTM
GMDN term
Pulmonary resuscitator, manual, single-use
Device class
Class II
Regulation number
868.5915
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary resuscitator, manual, single-use

Cleared under the same submission (K014115)

and 8 more cleared under K014115

Similar devices in this category

Other devices filed under Pulmonary resuscitator, manual, 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)