Cleared Traditional

K181034 - Pocket Colposcope System

K181034 is the FDA 510(k) clearance for Pocket Colposcope System by Hadleigh Health Technologies, LLC. It is a Class 2 Obstetrics & Gynecology device (product code HEX) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K181034 · Hadleigh Health Technologies, LLC · Obstetrics & Gynecology device
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Sep 2018
Decision
156d
Days
Class 2
Risk

K181034 is an FDA 510(k) clearance for the Pocket Colposcope System. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Hadleigh Health Technologies, LLC (San Rafael, US). The FDA issued a Cleared decision on September 21, 2018 after a review of 156 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.

View all Hadleigh Health Technologies, LLC devices

Submission Details

510(k) Number K181034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2018
Decision Date September 21, 2018
Days to Decision 156 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
4d faster than avg
Panel avg: 160d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

University of Utah
Spencer Walker

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 12
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K181034.
Smart Scope® CX
K233043 · Periwinkle Technologies Pvt., Ltd. · Jun 2024
Gynescope System
K190187 · Illumigyn , Ltd. · May 2019
Biop Digital Colposcope
K182764 · Biop Medical , Ltd. · Nov 2018
Video Colposcope
K151878 · Edan Instruments, Inc. · Dec 2015
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · CooperSurgical, Inc. · Oct 2014
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004