MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229— 510(k) K100367

Name: FDA 510(k) clearance K100367
Creator: U.S. Food and Drug Administration
Published: 2010-08-27

Substantially Equivalent

Origio A/S

FDA 510(k) clearance K100367 for MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229, Substantially Equivalent on 2010-08-27. Applicant: Origio A/S. Device class: 2.

Clearance details

Applicant: Origio A/S
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2010-02-12
Decision date: 2010-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

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K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)2026-08-28
K260248 — Ultra-Fast Warm2026-04-28
K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)2026-02-20
K250445 — Fast Warm - NX2025-09-12
K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more2025-08-27

More clearances from Origio A/S

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K200815 — VitriGuard2020-06-25
K180740 — VitriGuard2018-05-04
K173624 — ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)2018-03-02
K172197 — SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS2017-10-13
K161547 — Transem and EchoGen Embryo Transfer Catheters2017-03-09

Recalls naming K100367

K-number listed on FDA's recall record

Z-0100-2021 — MediCult Vitrification Cooling Media, Model Number 12284001FClass II·Terminated·CooperSurgical, Inc.·20200908

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100367.

Data sourced from openFDA. This site is unofficial and independent of the FDA.