Cleared Traditional

BREAST SHELL (K944177) - FDA 510(k) Clearance

Class I General Hospital device.

K944177 · O'Donnell, Byrne & Williams · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
40d
Days
Class 1
Risk

K944177 is an FDA 510(k) clearance for the BREAST SHELL. Classified as Shield, Nipple (product code HFS), Class I - General Controls.

Submitted by O'Donnell, Byrne & Williams (Chicago, US). The FDA issued a Cleared decision on October 5, 1994 after a review of 40 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all O'Donnell, Byrne & Williams devices

Submission Details

510(k) Number K944177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date October 05, 1994
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HFS Shield, Nipple
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5630
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.