Cleared Traditional

RELIANCE TEMPO OPHTH. INSTR STAND (K831568) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K831568 · F. & F. Koenigkramer · Obstetrics & Gynecology device
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Jun 1983
Decision
45d
Days
Class 1
Risk

K831568 is an FDA 510(k) clearance for the RELIANCE TEMPO OPHTH. INSTR STAND. Classified as Remover, Intrauterine Device, Contraceptive, Hook-type (product code HHF), Class I - General Controls.

Submitted by F. & F. Koenigkramer (Walker, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 45 days - a notably fast clearance cycle.

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: 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 F. & F. Koenigkramer devices

Submission Details

510(k) Number K831568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date June 30, 1983
Days to Decision 45 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
115d faster than avg
Panel avg: 160d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HHF Remover, Intrauterine Device, Contraceptive, Hook-type
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.