Cleared Traditional

K840325 - INFA COMPLETE BREAST PUMP & MILK STORAG

K840325 is an FDA 510(k) clearance for INFA COMPLETE BREAST PUMP & MILK STORAG, manufactured by Monterey Laboratories, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HGY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K840325 · Monterey Laboratories, Inc. · Obstetrics & Gynecology device
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Mar 1984
Decision
40d
Days
Class 1
Risk

K840325 is an FDA 510(k) clearance for the INFA COMPLETE BREAST PUMP & MILK STORAG. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Monterey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 40 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.

FDA 510(k) Submission Details - K840325

510(k) Number K840325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date March 05, 1984
Days to Decision 40 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
121d faster than avg
Panel avg: 161d · This submission: 40d
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 26
Devices cleared under the same product code (HGY) and FDA review panel - the closest regulatory comparables to K840325.
CRYSTAL MANUAL BREAST PUMP
K850242 · Crystal Medical Products, Inc. · Feb 1985
THE BIBICURE SYS BREAST TONER
K843544 · Les Entreprises Bibi, Inc. · Jan 1985
RODY BREAST PUMP
K840874 · Kean-Rody Manufacturer · Jul 1984
NEW MOTHER'S WAY-BREAST PUMP
K834399 · Huntleigh Technology, Inc. · Jan 1984
GENTLE FLOW BREAST PUMP
K833835 · Eklund & Co. · Nov 1983
BASIC BREAST PUMP
K831929 · Terayco Intl., Ltd. · Sep 1983
K840325 · INFA COMPLETE BREAST PUMP & MILK STORAG
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