Cleared Traditional

K831929 - BASIC BREAST PUMP

K831929 is an FDA 510(k) clearance for BASIC BREAST PUMP, manufactured by Terayco Intl., Ltd.. The device is a Class 1 Obstetrics & Gynecology device with product code HGY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K831929 · Terayco Intl., Ltd. · Obstetrics & Gynecology device
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Sep 1983
Decision
106d
Days
Class 1
Risk

K831929 is an FDA 510(k) clearance for the BASIC BREAST PUMP. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Terayco Intl., Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Terayco Intl., Ltd. devices

FDA 510(k) Submission Details - K831929

510(k) Number K831929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1983
Decision Date September 29, 1983
Days to Decision 106 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
54d faster than avg
Panel avg: 160d · This submission: 106d
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 10
Devices cleared under the same product code (HGY) and FDA review panel - the closest regulatory comparables to K831929.
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
MEDELA NAMUAL BREAST PUMP
K823840 · Medela, Inc. · Jan 1983
BREAST PUMP
K810100 · American Hospital Supply Corp. · Feb 1981
BREAST CARE KIT
K760911 · American Hospital Supply Corp. · Nov 1976