Cleared Traditional

K100385 - NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP

K100385 is an FDA 510(k) clearance for NUBY NATURAL TOUCH RHYTHM DUAL ACTION E..., manufactured by Luv N' Care, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K100385 · Luv N' Care, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
36d
Days
Class 2
Risk

K100385 is an FDA 510(k) clearance for the NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Luv N' Care, Ltd. (Austin, US). The FDA issued a Cleared decision on March 24, 2010 after a review of 36 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 Luv N' Care, Ltd. devices

FDA 510(k) Submission Details - K100385

510(k) Number K100385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date March 24, 2010
Days to Decision 36 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 160d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 164
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