Skip to content

Smartinfuser Painpump

by Precise Medical Products

510(k) K042122

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 · Traditional NumberK042122 Date22 Sep 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1982-2011 FDA Unclassified (pre-2012) initiated 17 Mar 2010

    Elastomeric tube in product's compression unit has the potential to burst following filling.

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  • Withdrawn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
MEB
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Precise Medical Products, Ltd.