Cleared Traditional

K052858 - SOOTHIES GEL PADS

K052858 is an FDA 510(k) clearance for SOOTHIES GEL PADS, manufactured by Puronxy, Inc.. The device is a Class 1 General Hospital device with product code NXH cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K052858 · Puronxy, Inc. · General Hospital
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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

FDA 510(k) Submission Details - K052858

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.

NXH Device Classification - Class 1, General Controls

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.