Cleared Traditional

K890385 - MIDWIFERY/OBSTETRICAL FORCEPS

K890385 is an FDA 510(k) clearance for MIDWIFERY/OBSTETRICAL FORCEPS, manufactured by Kinetic Medical Products. The device is a Class 2 Obstetrics & Gynecology device with product code HDA cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K890385 · Kinetic Medical Products · Obstetrics & Gynecology device
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Mar 1989
Decision
37d
Days
Class 2
Risk

K890385 is an FDA 510(k) clearance for the MIDWIFERY/OBSTETRICAL FORCEPS. Classified as Forceps, Obstetrical (product code HDA), Class II - Special Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on March 1, 1989 after a review of 37 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890385

510(k) Number K890385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date March 01, 1989
Days to Decision 37 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 160d · This submission: 37d
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.