Cleared Traditional

K073053 - COLPO-MASTER

K073053 is an FDA 510(k) clearance for COLPO-MASTER, manufactured by United Products & Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K073053 · United Products & Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
16d
Days
Class 2
Risk

K073053 is an FDA 510(k) clearance for the COLPO-MASTER. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by United Products & Instruments, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on November 15, 2007 after a review of 16 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.

FDA 510(k) Submission Details - K073053

510(k) Number K073053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2007
Decision Date November 15, 2007
Days to Decision 16 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d faster than avg
Panel avg: 161d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Citech
BOB MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K073053.
SEILER COLPOSCOPE, MODELS 935, 955 AND 985
K101141 · Seiler Precision Microscopes · Aug 2010
ECLERIS MICROSTAR COLPOSCOPE
K100595 · Ecleris USA · Jul 2010
CERVICAL MD, MODEL C10
K072691 · Sti Medical Systems · Jan 2008
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
K070845 · Sounmed, Inc. · Oct 2007
CO-1000 COLPOSCOPE, MULTIPLE
K061306 · Gynex Corp. · Aug 2006
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K073053 · COLPO-MASTER
Download PDF FDA Summary United Products & Ins…