Cleared Traditional

K923577 - BREAST SHELLS

K923577 is an FDA 510(k) clearance for BREAST SHELLS, manufactured by Medela, Inc.. The device is a Class 1 General Hospital device with product code HFS cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K923577 · Medela, Inc. · General Hospital
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Jan 1993
Decision
186d
Days
Class 1
Risk

K923577 is an FDA 510(k) clearance for the BREAST SHELLS. Classified as Shield, Nipple (product code HFS), Class I - General Controls.

Submitted by Medela, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1993 after a review of 186 days - an extended review 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: 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 Medela, Inc. devices

FDA 510(k) Submission Details - K923577

510(k) Number K923577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date January 22, 1993
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

HFS Device Classification - Class 1, General Controls

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.