Cleared Traditional

INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (K100517) - FDA 510(k) Clearance

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

K100517 · Instrumed International, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 2010
Decision
65d
Days
Class 2
Risk

K100517 is an FDA 510(k) clearance for the INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX. Classified as Forceps, Obstetrical (product code HDA), Class II - Special Controls.

Submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 29, 2010 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumed International, Inc. devices

Submission Details

510(k) Number K100517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2010
Decision Date April 29, 2010
Days to Decision 65 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 160d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDA Forceps, Obstetrical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4400
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.