Cleared Traditional

K061339 - HIERSPEC SPECULUM

K061339 is an FDA 510(k) clearance for HIERSPEC SPECULUM, manufactured by Medical Products Div.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K061339 · Medical Products Div. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
127d
Days
Class 2
Risk

K061339 is an FDA 510(k) clearance for the HIERSPEC SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Medical Products Div. (Indianapolis, US). The FDA issued a Cleared decision on September 19, 2006 after a review of 127 days - within the typical 510(k) review window.

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 - K061339

510(k) Number K061339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2006
Decision Date September 19, 2006
Days to Decision 127 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
34d faster than avg
Panel avg: 161d · This submission: 127d
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 65
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K061339.
MEDLINE DISPOSABLE VAGINAL SPECULUM
K072942 · Medline Industries, Inc. · Feb 2008
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
K072762 · Depalt, Inc. · Jan 2008
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
K070964 · Welch Allyn, Inc. · May 2007
IGS VAGINAL SPECULUM
K060129 · Innovative Gynecological Solutions, LLC · May 2006
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
K052420 · Gynova, LLC · Apr 2006
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
K052192 · Femspec LLC · Feb 2006
K061339 · HIERSPEC SPECULUM
Download PDF FDA Summary Medical Products Div.