Cleared Traditional

K983642 - COOK MINI-INCUBATOR

K983642 is the FDA 510(k) clearance for COOK MINI-INCUBATOR by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (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

Submission Details

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.

Device Classification

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 9
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K983642.
Geri Embryo Incubator and Geri Dish
K180304 · Genea Biomedx Pty, Ltd. · Apr 2018
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · Cook Urological, Inc. · Oct 1999
COOK TEST TUBE HEATER
K983609 · Cook Ob/Gyn · Dec 1998