Cleared Traditional

FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (K021193) - FDA 510(k) Clearance

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

K021193 · Fortune Medical Instrument Corp. · Obstetrics & Gynecology device
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Feb 2003
Decision
303d
Days
Class 2
Risk

K021193 is an FDA 510(k) clearance for the FORTUNE SILICONE VACUUM SUCTION, MODEL #1300. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Fortune Medical Instrument Corp. (Taipei Hsien, TW). The FDA issued a Cleared decision on February 12, 2003 after a review of 303 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.

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Submission Details

510(k) Number K021193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2002
Decision Date February 12, 2003
Days to Decision 303 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
143d slower than avg
Panel avg: 160d · This submission: 303d
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.