Cleared Traditional

K811403 - AXICARE BREAST PUMP MODEL

K811403 is the FDA 510(k) clearance for AXICARE BREAST PUMP MODEL by Neonatal Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HGX) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K811403 · Neonatal Corp. · Obstetrics & Gynecology device
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Jun 1981
Decision
25d
Days
Class 2
Risk

K811403 is an FDA 510(k) clearance for the AXICARE BREAST PUMP MODEL. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Neonatal Corp. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology 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 K811403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1981
Decision Date June 12, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 160d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.