Cleared Traditional

AXICARE BREAST SHELL (K811364) - FDA 510(k) Clearance

Class I General Hospital device.

K811364 · Neonatal Corp. · General Hospital
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Aug 1981
Decision
81d
Days
Class 1
Risk

K811364 is an FDA 510(k) clearance for the AXICARE BREAST SHELL. Classified as Shield, Nipple (product code HFS), Class I - General Controls.

Submitted by Neonatal Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1981 after a review of 81 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 Neonatal Corp. devices

Submission Details

510(k) Number K811364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1981
Decision Date August 03, 1981
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
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.