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Device (R1000 Ir Insulin Pump +4 more) - R1000 Ir Insulin Pump

by Animas Corp.

510(k) K021439

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 NumberK021439 Date29 May 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0307-06 FDA Unclassified (pre-2012) initiated 31 Oct 2005

    Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

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  • Withdrawn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
LZG
Models / Variants
R1000 Ir Insulin Pump
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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