Cleared Traditional

K160511 - Naya Breast Pump System

K160511 is an FDA 510(k) clearance for Naya Breast Pump System, manufactured by Naya Health, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K160511 · Naya Health, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
121d
Days
Class 2
Risk

K160511 is an FDA 510(k) clearance for the Naya Breast Pump System. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Naya Health, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 24, 2016 after a review of 121 days - within the typical 510(k) review window.

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 Naya Health, Inc. devices

FDA 510(k) Submission Details - K160511

510(k) Number K160511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2016
Decision Date June 24, 2016
Days to Decision 121 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
39d faster than avg
Panel avg: 160d · This submission: 121d
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 137
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K160511.
GCE704 Breast Pump
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Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
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Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
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MEDELA SWING BREAST PUMP
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