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Ambit Push & Play Ambulatory Infusion Pump

by Sorenson Medical, Inc.

510(k) K052221

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK052221 Date8 Dec 2005ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0185-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006
    • Terminated Z-0186-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006
    • Terminated Z-0187-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006
    • Terminated Z-0188-2007 FDA Unclassified (pre-2012) initiated 10 Oct 2006

    Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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