Cleared Traditional

K021042 - THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS

Also marketed or referenced as:
MODELS # 7456, 7457, 7458,7459,7475,7476

K021042 is an FDA 510(k) clearance for THERMO FORMA, manufactured by Thermo Forma, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K021042 · Thermo Forma, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
44d
Days
Class 2
Risk

K021042 is an FDA 510(k) clearance for the THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Thermo Forma, Inc. (Marietta, US). The FDA issued a Cleared decision on May 15, 2002 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thermo Forma, Inc. devices

FDA 510(k) Submission Details - K021042

510(k) Number K021042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date May 15, 2002
Days to Decision 44 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
116d faster than avg
Panel avg: 160d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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.

Regulatory Peers - MQG Accessory, Assisted Reproduction

All 29
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K021042.
EMBRYO VIEWER SOFTWARE
K113075 · Unisense Fertilitech A/S · Dec 2011
EMBRYOSCOPE
K111715 · Unisense Fertilitech A/S · Aug 2011
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc. · Nov 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000