Cleared Traditional

K941272 - KLEENSPEC

K941272 is an FDA 510(k) clearance for KLEENSPEC, manufactured by Welch Allyn, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K941272 · Welch Allyn, Inc. · Obstetrics & Gynecology device
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Aug 1994
Decision
139d
Days
Class 2
Risk

K941272 is an FDA 510(k) clearance for the KLEENSPEC. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 139 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 - K941272

510(k) Number K941272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1994
Decision Date August 02, 1994
Days to Decision 139 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 161d · This submission: 139d
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 K941272.
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
K963377 · North Eos Industries, Inc. · Oct 1996
VERSA-VU
K951898 · CooperSurgical, Inc. · Dec 1995
AMSINO DISPOSABLE VIGINAL SPECULUM
K951528 · Amsino Intl., Inc. · May 1995
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
K930954 · Cabot Medical Corp. · Jun 1994
INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION
K922154 · Olsen Electrosurgical, Inc. · Apr 1994
GRAVESPEC
K935636 · Adept-Med Intl., Inc. · Mar 1994
K941272 · KLEENSPEC
Download PDF Welch Allyn, Inc.