Cleared Traditional

K041952 - ZIVF-AIRE

K041952 is an FDA 510(k) clearance for ZIVF-AIRE, manufactured by Zander Medical Supplies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 415-day FDA review.

K041952 · Zander Medical Supplies, Inc. · Obstetrics & Gynecology device
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Sep 2005
Decision
415d
Days
Class 2
Risk

K041952 is an FDA 510(k) clearance for the ZIVF-AIRE. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Zander Medical Supplies, Inc. (Vero Beach, US). The FDA issued a Cleared decision on September 8, 2005 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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.

FDA 510(k) Submission Details - K041952

510(k) Number K041952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2004
Decision Date September 08, 2005
Days to Decision 415 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
254d slower than avg
Panel avg: 161d · This submission: 415d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 46
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K041952 · ZIVF-AIRE
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