Cleared Traditional

K914541 - SPERM MAINTENANCE MEDIUM WITH GLYCEROL

K914541 is an FDA 510(k) clearance for SPERM MAINTENANCE MEDIUM WITH GLYCEROL, manufactured by Irvine Scientific. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 846-day FDA review.

K914541 · Irvine Scientific · Obstetrics & Gynecology device
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Feb 1994
Decision
846d
Days
Class 2
Risk

K914541 is an FDA 510(k) clearance for the SPERM MAINTENANCE MEDIUM WITH GLYCEROL. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 846 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 Irvine Scientific devices

FDA 510(k) Submission Details - K914541

510(k) Number K914541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date February 03, 1994
Days to Decision 846 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
686d slower than avg
Panel avg: 160d · This submission: 846d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MFD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MFD Cannula, Intrauterine Insemination

All 19
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K914541.
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
K940176 · Ackrad Laboratories · Apr 1996
INSEMI-CATH II
K954398 · Cook Urological, Inc. · Dec 1995
INSEMI-CATH
K931630 · Cook Ob/Gyn · Apr 1994
MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
K923612 · Life-Tech Intl., Inc. · Sep 1993
MODIFIED F-10 CULTURE MEDIUM
K923634 · Life-Tech Intl., Inc. · Sep 1993
DISTILLED WATER
K923651 · Life-Tech Intl., Inc. · Sep 1993