Cleared Traditional

K142168 - NATURE'S BOND 600 AND NATURE'S BOND 603

K142168 is an FDA 510(k) clearance for NATURE'S BOND 600 AND NATURE'S BOND 603, manufactured by Devon Medical Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K142168 · Devon Medical Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
120d
Days
Class 2
Risk

K142168 is an FDA 510(k) clearance for the NATURE'S BOND 600 AND NATURE'S BOND 603. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Devon Medical Products, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on December 4, 2014 after a review of 120 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 Devon Medical Products, Inc. devices

FDA 510(k) Submission Details - K142168

510(k) Number K142168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2014
Decision Date December 04, 2014
Days to Decision 120 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
40d faster than avg
Panel avg: 160d · This submission: 120d
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 148
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K142168.
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
K151632 · Medela AG · Nov 2015
Melodi Prime Breast Pump
K143574 · Genadyne Biotechnologies, Inc. · Apr 2015
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
K150499 · Medela AG · Apr 2015
LUCINA-MELODI
K112856 · Genadyne Biotechnologies, Inc. · May 2012
LUCINA MODEL MELODI
K102516 · Genadyne Biotechnologies, Inc. · Aug 2011
MEDELA SWING BREAST PUMP
K053052 · Medela AG · May 2006