Cleared Traditional

K030761 - KAISHOU VAGINAL SPECULUM

K030761 is an FDA 510(k) clearance for KAISHOU VAGINAL SPECULUM, manufactured by Jiangsu Kaishou Medical Apparatus Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030761 · Jiangsu Kaishou Medical Apparatus Co., Ltd. · Obstetrics & Gynecology device
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Jun 2003
Decision
90d
Days
Class 2
Risk

K030761 is an FDA 510(k) clearance for the KAISHOU VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Jiangsu Kaishou Medical Apparatus Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 9, 2003 after a review of 90 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 - K030761

510(k) Number K030761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2003
Decision Date June 09, 2003
Days to Decision 90 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
71d faster than avg
Panel avg: 161d · This submission: 90d
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 K030761.
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950 · Panatrex, Inc. · Nov 2004
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
K040817 · Advanced Urological Developments · Jun 2004
KENTEX DISPOSABLE VAGINAL SPECULUM
K030693 · Kentron Health Care, Inc. · Aug 2003
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
K022948 · Medical Action Industries, Inc. · Nov 2002
TAGG DISPOSABLE VAGINAL SPECULUM
K021849 · Tagg Industries · Jul 2002
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · Cypress Medical Products, Ltd. · Jul 2002
K030761 · KAISHOU VAGINAL SPECULUM
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