Cleared Traditional

K823591 - AMEDA HAND BREAST PUMP (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K823591 · Burditt & Calkins-Siemens-Elema · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
22d
Days
Class 1
Risk

K823591 is an FDA 510(k) clearance for the AMEDA HAND BREAST PUMP. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Burditt & Calkins-Siemens-Elema (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5150 - 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 Burditt & Calkins-Siemens-Elema devices

Submission Details

510(k) Number K823591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date December 28, 1982
Days to Decision 22 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
138d faster than avg
Panel avg: 160d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HGY Pump, Breast, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5150
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.