Skip to content

Ambit Intermittent Ambulatory Infusion Pump

by Sorenson Medical, Inc.

510(k) K033425

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Special NumberK033425 Date6 Nov 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1188-06 FDA Unclassified (pre-2012) initiated 3 May 2006

    Intermittent Infusion pump may continually dispense medication under certain conditions.

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  • Withdrawn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

Other devices from Sorenson Medical, Inc.