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Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-Pp-9, 16-Pp-5.75

by Humagen Fertility Diagnostics, Inc.

510(k) K000915

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK000915 Date12 May 2000ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1946-2014 FDA Class II initiated 20 Jun 2014

    Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration

    • Terminated Z-1220-2007 FDA Unclassified (pre-2012) initiated 8 May 2007

    Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

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  • Withdrawn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
MQK
Device Class
Class II
Regulation
21 CFR Part 884.6160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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