Cleared Traditional

K823840 - MEDELA NAMUAL BREAST PUMP

K823840 is an FDA 510(k) clearance for MEDELA NAMUAL BREAST PUMP, manufactured by Medela, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HGY cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K823840 · Medela, Inc. · Obstetrics & Gynecology device
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Jan 1983
Decision
34d
Days
Class 1
Risk

K823840 is an FDA 510(k) clearance for the MEDELA NAMUAL BREAST PUMP. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Medela, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1983 after a review of 34 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 Medela, Inc. devices

FDA 510(k) Submission Details - K823840

510(k) Number K823840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date January 24, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 160d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

HGY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HGY Pump, Breast, Non-powered

All 9
Devices cleared under the same product code (HGY) and FDA review panel - the closest regulatory comparables to K823840.
MOTHERS TOUCH ONE HAND BREAST PUMP
K912355 · Hollister, Inc. · Dec 1993
SUPPLEMENTAL FEEDING SYSTEM
K844297 · Medela, Inc. · Feb 1985
NEW MOTHER'S WAY-BREAST PUMP
K834399 · Huntleigh Technology, Inc. · Jan 1984
BREAST PUMP
K810100 · American Hospital Supply Corp. · Feb 1981
BREAST CARE KIT
K760911 · American Hospital Supply Corp. · Nov 1976