Cleared Traditional

FERRIS POLYMEM STERILE BREAST PAD (K031660) - FDA 510(k) Clearance

Class I General Hospital device.

K031660 · Ferris Mfg. Corp. · General Hospital
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Feb 2005
Decision
636d
Days
Class 1
Risk

K031660 is an FDA 510(k) clearance for the FERRIS POLYMEM STERILE BREAST PAD. Classified as Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68) (product code NTX), Class I - General Controls.

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on February 22, 2005 after a review of 636 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Ferris Mfg. Corp. devices

Submission Details

510(k) Number K031660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2003
Decision Date February 22, 2005
Days to Decision 636 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
507d slower than avg
Panel avg: 129d · This submission: 636d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5630
Definition A Nursing Pad Consisting Of A Polyurethane Pad With Glycerin Used To Relieve Nipples That Are Sore And Cracked From Breastfeeding.
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.