Cleared Traditional

CRYOPETTE (K100596) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100596 · Mid-Atlantic Diagnostics, Inc. · Obstetrics & Gynecology device
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Dec 2010
Decision
279d
Days
Class 2
Risk

K100596 is an FDA 510(k) clearance for the CRYOPETTE. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Mid-Atlantic Diagnostics, Inc. (Sandy Spring, US). The FDA issued a Cleared decision on December 6, 2010 after a review of 279 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mid-Atlantic Diagnostics, Inc. devices

Submission Details

510(k) Number K100596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2010
Decision Date December 06, 2010
Days to Decision 279 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 160d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

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All 49
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