Cleared Traditional

K992070 - COOK ULTRA QUIET VACUUM PUMP & REGULATOR

K992070 is an FDA 510(k) clearance for COOK ULTRA QUIET VACUUM PUMP & REGULATOR, manufactured by Cook Urological, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K992070 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
131d
Days
Class 2
Risk

K992070 is an FDA 510(k) clearance for the COOK ULTRA QUIET VACUUM PUMP & REGULATOR. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 131 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 Urological, Inc. devices

FDA 510(k) Submission Details - K992070

510(k) Number K992070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1999
Decision Date October 27, 1999
Days to Decision 131 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
29d faster than avg
Panel avg: 160d · This submission: 131d
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 22
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K992070.
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc. · Nov 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
K000394 · Rocket Medical Plc · Feb 2000
HOFFMAN IVF-1
K991216 · (Arms) Hoffman Surgical Equipment, Ivf Division · Aug 1999
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
K991408 · Thermoquest Corp. · Jul 1999
THERMOPLATE
K991263 · Tokai Hit Co., Ltd. · Jul 1999