Cleared Traditional

K001314 - MEDSCOPE

K001314 is an FDA 510(k) clearance for MEDSCOPE, manufactured by All-Pro Imaging Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K001314 · All-Pro Imaging Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 2000
Decision
90d
Days
Class 2
Risk

K001314 is an FDA 510(k) clearance for the MEDSCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by All-Pro Imaging Corp. (Hicksville, US). The FDA issued a Cleared decision on July 25, 2000 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K001314

510(k) Number K001314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2000
Decision Date July 25, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 161d · This submission: 90d
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 54
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K001314.
INTERMED ZOOM COLPOSCOPE
K031639 · Intermed Group, Inc. · Aug 2003
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
K021153 · Goldway Us, Inc. · Feb 2003
DFV CPG COLPOSCOPE
K021854 · D.F. Vasconcellos S.A. · Oct 2002
LEICA COLPOSCOPE
K000707 · Leica Microscopy Systems , Ltd. · Jun 2000
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K992544 · Circon Corp. · Oct 1999
LEISEGANG VIDEO COLPOSCOPE
K981958 · Netoptix Corp. · Oct 1998
K001314 · MEDSCOPE
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