Cleared Traditional

K002696 - WHITTLESTONE BREASTPUMP

K002696 is an FDA 510(k) clearance for WHITTLESTONE BREASTPUMP, manufactured by Whittlestone, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K002696 · Whittlestone, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
203d
Days
Class 2
Risk

K002696 is an FDA 510(k) clearance for the WHITTLESTONE BREASTPUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Whittlestone, Inc. (Benicia, US). The FDA issued a Cleared decision on March 21, 2001 after a review of 203 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 Whittlestone, Inc. devices

FDA 510(k) Submission Details - K002696

510(k) Number K002696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date March 21, 2001
Days to Decision 203 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 160d · This submission: 203d
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 166
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K002696.
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
K031614 · Medela, Inc. · Jun 2003
PLAYTEX BREAST PUMP
K022594 · Playtex Products, Inc. · Nov 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · Medela, Inc. · Mar 2002
LACTATION TECHNIQUES MODEL B
K981549 · Lactation Techniques, Inc. · May 1999
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
K983776 · Evenflo Co., Inc. · Apr 1999
EXPRESSE AND PREMIER POWERED BREAST PUMPS
K973501 · Ameda Medizintechnik AG · Dec 1997