Cleared Traditional

K884934 - JEDMED KP6 COLPOSCOPE

K884934 is an FDA 510(k) clearance for JEDMED KP6 COLPOSCOPE, manufactured by Jedmed Instrument Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K884934 · Jedmed Instrument Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
87d
Days
Class 2
Risk

K884934 is an FDA 510(k) clearance for the JEDMED KP6 COLPOSCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1630 - 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 Jedmed Instrument Co. devices

FDA 510(k) Submission Details - K884934

510(k) Number K884934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date February 23, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEX Device Classification - Class 2, Special Controls

Product Code HEX Colposcope (and Colpomicroscope)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1630
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 - HEX Colposcope (and Colpomicroscope)

All 37
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K884934.
IMT LOUPE-COLPOSCOPE
K963593 · Inventive Medical Technology · Apr 1997
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K955635 · Welch Allyn, Inc. · May 1996
MALLEABLE PLACENTA CURETTE
K890387 · Kinetic Medical Products · Feb 1989
PHOTOSTAR V-8
K871681 · Wallach Surgical Devices, Inc. · Aug 1987
COLPOSTAR V-6
K871683 · Wallach Surgical Devices, Inc. · Aug 1987
WALLACH CONVERTIBLE COLPOSCOPE
K871682 · Wallach Surgical Devices, Inc. · Jun 1987