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Halyard 13568

by Avanos Medical, Inc.

Halyard 13568 (C270050) is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K052117 on 9 Sep 2005 and listed in FDA GUDID since 15 Mar 2017 (UDI-DI 10680651135688), active as of 23 Oct 2026. 3 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

3 closed

Documents

510(k) K052117

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 Number10680651135688 UDI-DI Date15 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK052117 Date9 Sep 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052117 decided 9 Sep 2005 Active
  • FDA GUDID UDI-DI 10680651135688 listed 15 Mar 2017 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2111-2009 FDA Unclassified (pre-2012) initiated 11 Feb 2008

    I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the correct and incorrect part looks like). Lot 612996 was manufactured on January 6, 2006. As of February 7, 2008, there have been no further complaints received on t

  • 2 recalls, same reason

    • Terminated Z-0584-06 FDA Unclassified (pre-2012) initiated 17 Jan 2006
    • Terminated Z-0585-06 FDA Unclassified (pre-2012) initiated 17 Jan 2006

    The sterile pack may contain the wrong infusion pump inside.

Timeline

5 dated events

  1. Cleared FDA 510(k) K052117
  2. Recall initiated FDA recalls Z-0584-06
  3. Recall initiated FDA recalls Z-0585-06
  4. Recall initiated FDA recalls Z-2111-2009
  5. Listed FDA GUDID 10680651135688

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  • Withdrawn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
Elastomeric infusion pump system
Model / Ref / Catalog
13568, C270050
Primary DI / UDI-DI
10680651135688
510(k) Number
FDA product code
MEB
GMDN term
Elastomeric infusion pump system
Device class
Class II
Regulation number
880.5725
GUDID distribution status
In Commercial Distribution

Related devices

Category: Elastomeric infusion pump system

Cleared under the same submission (K052117)

and 8 more cleared under K052117

Similar devices in this category

Other devices filed under Elastomeric infusion pump system.

Other devices from Avanos Medical, Inc.

See all devices from Avanos Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)