Skip to content

Halyard SS010SFR

by Owens & Minor Distribution, Inc.

Halyard SS010SFR is a Class II device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K201286 on 11 Aug 2020 and listed in FDA GUDID since 28 Nov 2023 (UDI-DI 10885632389849), active as of 23 Oct 2026. 2 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

2 ongoing

This device is named in the recall

Documents

510(k) K201286

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 Number10885632389849 UDI-DI Date28 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201286 Date11 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201286 decided 11 Aug 2020 Active
  • FDA GUDID UDI-DI 10885632389849 listed 28 Nov 2023 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0511-2024 FDA Class I initiated 6 Nov 2023
    • Ongoing Z-0512-2024 FDA Class I initiated 6 Nov 2023

    Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

Timeline

4 dated events

  1. Cleared FDA 510(k) K201286
  2. Recall initiated FDA recalls Z-0511-2024
  3. Recall initiated FDA recalls Z-0512-2024
  4. Listed FDA GUDID 10885632389849

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  • Withdrawn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
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Model / reference
SS010SFR
Description
Prefilled Syringe Saline Flush Intravenous 10ML PP Clear Sterile Field IV Flush CA/240 Not made with Natural Rubber Latex Halyard
Primary DI / UDI-DI
10885632389849
510(k) Number
FDA product code
NGT
GMDN term
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

Cleared under the same submission (K201286)

Similar devices in this category

Other devices filed under Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.

Other devices from Owens & Minor Distribution, Inc.

See all devices from Owens & Minor Distribution, Inc. →

Properties

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