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Hudson Rci IPN042769

by Teleflex Incorporated

Hudson Rci IPN042769 (1750) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K781831 on 15 Dec 1978 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04026704595532), 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) K781831

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 Number04026704595532 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK781831 Date15 Dec 1978DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K781831 decided 15 Dec 1978 Active
  • FDA GUDID UDI-DI 04026704595532 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K781831
  2. Listed FDA GUDID 04026704595532

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hudson Rci
Generic name
Incentive spirometer
Model / Ref / Catalog
IPN042769, 1750
Primary DI / UDI-DI
04026704595532
510(k) Number
FDA product code
BWF
GMDN term
Incentive spirometer
Device class
Class II
Regulation number
868.5690
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code BWF (SPIROMETER, THERAPEUTIC (INCENTIVE)).

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Properties

  • Single use
Other properties (14, all answered No)