Skip to content

Hudson Rci IPN042719

by Teleflex Incorporated

Hudson Rci IPN042719 (1683) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K871157 on 21 Apr 1987 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04026704595211), active as of 23 Oct 2026. 5 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

5 closed

Documents

510(k) K871157

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 Number04026704595211 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK871157 Date21 Apr 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K871157 decided 21 Apr 1987 Active
  • FDA GUDID UDI-DI 04026704595211 listed 16 Sep 2016 Listed

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0861-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007
    • Terminated Z-0859-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007
    • Terminated Z-0858-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007
    • Terminated Z-0860-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007
    • Terminated Z-0857-2007 FDA Unclassified (pre-2012) initiated 23 Mar 2007

    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.

Timeline

7 dated events

  1. Cleared FDA 510(k) K871157
  2. Recall initiated FDA recalls Z-0861-2007
  3. Recall initiated FDA recalls Z-0859-2007
  4. Recall initiated FDA recalls Z-0858-2007
  5. Recall initiated FDA recalls Z-0860-2007
  6. Recall initiated FDA recalls Z-0857-2007
  7. Listed FDA GUDID 04026704595211

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  • Withdrawn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
Nasal oxygen cannula, CPAP
Model / Ref / Catalog
IPN042719, IPN913699, 1683
Primary DI / UDI-DI
04026704595211, 14026704659040
510(k) Number
FDA product code
BZD
GMDN term
Nasal oxygen cannula, CPAP
Device class
Class II
Regulation number
868.5905
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal oxygen cannula, CPAP

Cleared under the same submission (K871157)

and 8 more cleared under K871157

Similar devices in this category

Other devices filed under Nasal oxygen cannula, CPAP.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

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