Cleared Traditional

AMNIPERF(TM) (K926425) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K926425 · Raymart Development Co. · Obstetrics & Gynecology device
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Mar 1994
Decision
439d
Days
Class 1
Risk

K926425 is an FDA 510(k) clearance for the AMNIPERF(TM). Classified as Amniotome (product code HGE), Class I - General Controls.

Submitted by Raymart Development Co. (Atlanta, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Raymart Development Co. devices

Submission Details

510(k) Number K926425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date March 07, 1994
Days to Decision 439 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 160d · This submission: 439d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HGE Amniotome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
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.