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FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

by International Biophysics Corp.

510(k) K170029

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 NumberK170029 Date15 Dec 2017ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0318-2021 FDA Class II initiated 24 Jun 2019

    The firm has become aware that they have distributed product that was expired.

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  • Withdrawn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
KFM
FDA applicant
International Biophysics Corporation
Device Class
Class II
Regulation
21 CFR Part 870.4360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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