Cleared Traditional

K810065 - SCOTT CM42 PASTEURIZER

K810065 is an FDA 510(k) clearance for SCOTT CM42 PASTEURIZER, manufactured by William Harvey Life Products Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810065 · William Harvey Life Products Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1981
Decision
15d
Days
Class 2
Risk

K810065 is an FDA 510(k) clearance for the SCOTT CM42 PASTEURIZER. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by William Harvey Life Products Corp. (Walker, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - 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 William Harvey Life Products Corp. devices

FDA 510(k) Submission Details - K810065

510(k) Number K810065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date January 28, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 161d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
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 - HGX Pump, Breast, Powered

All 226
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K810065.
EGNELL ELITE
K950531 · Hollister, Inc. · Sep 1995
MEDELA BATTERY OPERATED BREAST PUMP
K901344 · Medela, Inc. · Aug 1990
MEDELA BREAST-PUMP LACTINA
K875300 · Medela, Inc. · Apr 1988
MEDELA ELECTRIC BREAST PUMP
K801862 · Medela, Inc. · Oct 1980
OXFORD HUMAN MILK PASTEURISER
K801246 · Vickers America Medical Corp. · Oct 1980