Cleared Traditional

K100517 - INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX

K100517 is an FDA 510(k) clearance for INSTRUMED FORCEPS OBSTERICAL, manufactured by Instrumed International, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K100517 · Instrumed International, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K100517

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.

HDA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HDA Forceps, Obstetrical

Devices cleared under the same product code (HDA) and FDA review panel - the closest regulatory comparables to K100517.
V. MUELLER OBSTETRICAL (OB) FORCEPS
K951529 · Baxter Healthcare Corp · Aug 1995
AUTO SUTURE(R) ENDOSCOPIC CLAMP
K903205 · United States Surgical, A Division of Tyco Healthc · Oct 1990
MIDWIFERY/OBSTETRICAL FORCEPS
K890385 · Kinetic Medical Products · Mar 1989
SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420
K851883 · The Huxley Instrument Corp. · May 1985