Cleared Traditional

K070435 - DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400

K070435 is an FDA 510(k) clearance for DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC..., 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 152-day FDA review.

K070435 · Whittlestone, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
152d
Days
Class 2
Risk

K070435 is an FDA 510(k) clearance for the DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Whittlestone, Inc. (Castle Rock, US). The FDA issued a Cleared decision on July 17, 2007 after a review of 152 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 - K070435

510(k) Number K070435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2007
Decision Date July 17, 2007
Days to Decision 152 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 160d · This submission: 152d
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

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