Cleared Traditional

K840308 - CAT. 4-OBSTETRICS GYNECOLOGY DEV'S

K840308 is the FDA 510(k) clearance for CAT. 4-OBSTETRICS GYNECOLOGY DEV'S by Imm Enterprises , Ltd.. It is a Class 1 Obstetrics & Gynecology device (product code KOH) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K840308 · Imm Enterprises , Ltd. · Obstetrics & Gynecology device
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Mar 1984
Decision
41d
Days
Class 1
Risk

K840308 is an FDA 510(k) clearance for the CAT. 4-OBSTETRICS GYNECOLOGY DEV'S. Classified as Instrument, Manual, General Obstetric-gynecologic (product code KOH), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4520 - 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 Imm Enterprises , Ltd. devices

Submission Details

510(k) Number K840308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date March 05, 1984
Days to Decision 41 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
119d faster than avg
Panel avg: 160d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOH Instrument, Manual, General Obstetric-gynecologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4520
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 - KOH Instrument, Manual, General Obstetric-gynecologic

Devices cleared under the same product code (KOH) and FDA review panel - the closest regulatory comparables to K840308.
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