Cleared Traditional

K072942 - MEDLINE DISPOSABLE VAGINAL SPECULUM

K072942 is an FDA 510(k) clearance for MEDLINE DISPOSABLE VAGINAL SPECULUM, manufactured by Medline Industries, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K072942 · Medline Industries, Inc. · Obstetrics & Gynecology device
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Feb 2008
Decision
114d
Days
Class 2
Risk

K072942 is an FDA 510(k) clearance for the MEDLINE DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 114 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 - K072942

510(k) Number K072942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2007
Decision Date February 08, 2008
Days to Decision 114 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
47d faster than avg
Panel avg: 161d · This submission: 114d
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
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K072942 · MEDLINE DISPOSABLE VAGINAL SPECULUM
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