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Portex G1732

by ICU Medical, Inc.

Portex G1732 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K911638 on 21 Jun 1991 and listed in FDA GUDID since 29 Dec 2016 (UDI-DI 10351688070562), active as of 23 Oct 2026.

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

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) K911638

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 Number10351688070562 UDI-DI Date29 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK911638 Date21 Jun 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K911638 decided 21 Jun 1991 Active
  • FDA GUDID UDI-DI 10351688070562 listed 29 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K911638
  2. Listed FDA GUDID 10351688070562

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  • Withdrawn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
Blood transfusion filter
Model / reference
G1732
Primary DI / UDI-DI
10351688070562
510(k) Number
FDA product code
JKA
GMDN term
Blood transfusion filter
Device class
Class II
Regulation number
862.1675
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Blood transfusion filter

Similar devices in this category

Other devices filed under Blood transfusion filter.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)