Cleared Traditional

SOOTHIES GEL PADS (K052858) - FDA 510(k) Clearance

Class I General Hospital device.

K052858 · Puronxy, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
121d
Days
Class 1
Risk

K052858 is an FDA 510(k) clearance for the SOOTHIES GEL PADS. Classified as Nursing Pad, Cohesive Gel (product code NXH), Class I - General Controls.

Submitted by Puronxy, Inc. (San Diego, US). The FDA issued a Cleared decision on February 9, 2006 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5630 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Puronxy, Inc. devices

Submission Details

510(k) Number K052858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date February 09, 2006
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NXH Nursing Pad, Cohesive Gel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5630
Definition Intended To Relieve Nipples That Are Sore And Cracked From Breast Feeding.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.