Cleared Traditional

K012535 - DRG DISPOSABLE VAGINAL SPECULUM

K012535 is an FDA 510(k) clearance for DRG DISPOSABLE VAGINAL SPECULUM, manufactured by Doctor'S Research Group, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K012535 · Doctor'S Research Group, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
206d
Days
Class 2
Risk

K012535 is an FDA 510(k) clearance for the DRG DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Wolcott, US). The FDA issued a Cleared decision on March 1, 2002 after a review of 206 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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 - K012535

510(k) Number K012535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date March 01, 2002
Days to Decision 206 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
45d slower than avg
Panel avg: 161d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HIB Speculum, Vaginal, Nonmetal

All 71
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K012535.
GLO-SPEC I, II AND III
K020959 · Sol Weiss MD, Inc. · Jun 2002
LEESPEC DISPOSABLE VAGINAL SPECULUM
K021017 · Itl Corporation Pty, Ltd. · Jun 2002
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
K020726 · Dukal Corp. · May 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · Dynascend Consulting Int'L, LLC · Jan 2002
GLO-SPEC
K013817 · Sol Weiss MD, Inc. · Dec 2001
NU-SPEC D
K012859 · Sol Weiss MD, Inc. · Oct 2001
K012535 · DRG DISPOSABLE VAGINAL SPECULUM
Download PDF FDA Summary Doctor'S Research Gro…