Cleared Traditional

K021849 - TAGG DISPOSABLE VAGINAL SPECULUM

K021849 is the FDA 510(k) clearance for TAGG DISPOSABLE VAGINAL SPECULUM by Tagg Industries. It is a Class 2 Obstetrics & Gynecology device (product code HIB) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K021849 · Tagg Industries · Obstetrics & Gynecology device
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Jul 2002
Decision
41d
Days
Class 2
Risk

K021849 is an FDA 510(k) clearance for the TAGG DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Tagg Industries (Laguna Hills, US). The FDA issued a Cleared decision on July 16, 2002 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tagg Industries devices

Submission Details

510(k) Number K021849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2002
Decision Date July 16, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 160d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K021849.
SPECULUM, VAGINAL, NONMETAL
K120743 · Welch Allyn, Inc. · Mar 2012
MEDLINE DISPOSABLE VAGINAL SPECULUM
K072942 · Medline Industries, Inc. · Feb 2008
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
K070964 · Welch Allyn, Inc. · May 2007
NYLON COATED SPECULA
K925501 · Zinnanti Surgical Instruments, Inc. · Jun 1997
KLEENSPEC
K941272 · Welch Allyn, Inc. · Aug 1994
DISPOSABLE PLASTIC VAGINAL SPECULA
K894957 · Zinnanti Surgical Instruments, Inc. · Oct 1989