Cleared Traditional

K893545 - IVEX MODEL NO. BP 3000 BREASTPUMP

K893545 is an FDA 510(k) clearance for IVEX MODEL NO. BP 3000 BREASTPUMP, manufactured by Ivex Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K893545 · Ivex Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
284d
Days
Class 2
Risk

K893545 is an FDA 510(k) clearance for the IVEX MODEL NO. BP 3000 BREASTPUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Ivex Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 284 days - an extended review 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: 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 Ivex Medical, Inc. devices

FDA 510(k) Submission Details - K893545

510(k) Number K893545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date February 16, 1990
Days to Decision 284 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
124d slower than avg
Panel avg: 160d · This submission: 284d
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 211
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K893545.
MEDELAS BREAST PUMP
K950750 · Medela, Inc. · Oct 1995
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