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Cryopette

by Mid-Atlantic Diagnostics, Inc.

510(k) K100596

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 NumberK100596 Date6 Dec 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1094-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011

    Cryopettes were rupturing during the warming process following vitrification.

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  • Withdrawn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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