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Halyard 76767

by O&M Halyard Inc.

Halyard 76767 is a Class II device made by O&M Halyard Inc., cleared under FDA 510(k) K974068 on 22 Dec 1997 and listed in FDA GUDID since 18 Nov 2020 (UDI-DI 20680651767671), active as of 23 Oct 2026. One FDA recall is 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) K974068

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 Number20680651767671 UDI-DI Date18 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974068 Date22 Dec 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974068 decided 22 Dec 1997 Active
  • FDA GUDID UDI-DI 20680651767671 listed 18 Nov 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2626-2023 FDA Class II initiated 9 Aug 2023

    One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

Timeline

3 dated events

  1. Cleared FDA 510(k) K974068
  2. Listed FDA GUDID 20680651767671
  3. Recall initiated FDA recalls Z-2626-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Halyard
Generic name
Surgical/medical respirator, non-antimicrobial, single-use
Model / Ref / Catalog
76767
Primary DI / UDI-DI
20680651767671
510(k) Number
FDA product code
MSH
GMDN term
Surgical/medical respirator, non-antimicrobial, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical respirator, non-antimicrobial, single-use

Cleared under the same submission (K974068)

and 2 more cleared under K974068

Similar devices

Other devices filed under FDA product code MSH (Respirator, surgical).

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)