Cleared Traditional

K070845 - SOUNMED COLOPOSCOPE COLPO-99/99PLUS

K070845 is an FDA 510(k) clearance for SOUNMED COLOPOSCOPE COLPO-99/99PLUS, manufactured by Sounmed, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K070845 · Sounmed, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
199d
Days
Class 2
Risk

K070845 is an FDA 510(k) clearance for the SOUNMED COLOPOSCOPE COLPO-99/99PLUS. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Sounmed, Inc. (Miami, US). The FDA issued a Cleared decision on October 12, 2007 after a review of 199 days - an extended review 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: 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 - K070845

510(k) Number K070845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2007
Decision Date October 12, 2007
Days to Decision 199 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 161d · This submission: 199d
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 49
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K070845.
ECLERIS MICROSTAR COLPOSCOPE
K100595 · Ecleris USA · Jul 2010
CERVICAL MD, MODEL C10
K072691 · Sti Medical Systems · Jan 2008
COLPO-MASTER
K073053 · United Products & Instruments, Inc. · Nov 2007
CO-1000 COLPOSCOPE, MULTIPLE
K061306 · Gynex Corp. · Aug 2006
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004
MEDISCOPE
K031436 · Sometech Corporation · Dec 2003
K070845 · SOUNMED COLOPOSCOPE COLPO-99/99PLUS
Download PDF FDA Summary Sounmed, Inc.