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Medro Spd

by Usfilter/Ionpure, Inc.

510(k) K030652

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 NumberK030652 Date3 Sep 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0798-05 FDA Unclassified (pre-2012) initiated 28 Feb 2005

    Incorrect type of stainless steel firm used 303 vs 316

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  • Withdrawn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
FIP
Device Class
Class II
Regulation
21 CFR Part 876.5665
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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