Cleared Traditional

K983642 - COOK MINI-INCUBATOR

K983642 is an FDA 510(k) clearance for COOK MINI-INCUBATOR, manufactured by Cook Ob/Gyn. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K983642 · Cook Ob/Gyn · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
108d
Days
Class 2
Risk

K983642 is an FDA 510(k) clearance for the COOK MINI-INCUBATOR. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on February 1, 1999 after a review of 108 days - within the typical 510(k) review window.

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: 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 Cook Ob/Gyn devices

FDA 510(k) Submission Details - K983642

510(k) Number K983642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1998
Decision Date February 01, 1999
Days to Decision 108 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 160d · This submission: 108d
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 30
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K983642.
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
K991408 · Thermoquest Corp. · Jul 1999
THERMOPLATE
K991263 · Tokai Hit Co., Ltd. · Jul 1999
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
K991229 · Henning Knudsen Engineering A/S · Jun 1999
COOK TEST TUBE HEATER
K983609 · Cook Ob/Gyn · Dec 1998