Cleared Traditional

LIFETEK IUI CATHETER (K921518) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921518 · Lifetek Medical, Inc. · Obstetrics & Gynecology device
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May 1994
Decision
770d
Days
Class 2
Risk

K921518 is an FDA 510(k) clearance for the LIFETEK IUI CATHETER. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Lifetek Medical, Inc. (Deforest, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 770 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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 Lifetek Medical, Inc. devices

Submission Details

510(k) Number K921518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date May 10, 1994
Days to Decision 770 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
610d slower than avg
Panel avg: 160d · This submission: 770d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.