Cleared Traditional

K913324 - MITYVAC SAFTISOFT OBSTETRICAL VACUUM DE...

K913324 is the FDA 510(k) clearance for MITYVAC SAFTISOFT OBSTETRICAL VACUUM DE... by Neward Enterprises, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HDB) cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K913324 · Neward Enterprises, Inc. · Obstetrics & Gynecology device
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Jun 1992
Decision
333d
Days
Class 2
Risk

K913324 is an FDA 510(k) clearance for the MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Neward Enterprises, Inc. (Cucamonga, US). The FDA issued a Cleared decision on June 22, 1992 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4340 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neward Enterprises, Inc. devices

Submission Details

510(k) Number K913324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date June 22, 1992
Days to Decision 333 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
173d slower than avg
Panel avg: 160d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDB Extractor, Vacuum, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4340
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 - HDB Extractor, Vacuum, Fetal

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