Cleared Traditional

LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (K091754) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091754 · Lune Group , Ltd. · Obstetrics & Gynecology device
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Nov 2009
Decision
150d
Days
Class 2
Risk

K091754 is an FDA 510(k) clearance for the LUNETTE MENSTRUAL CUP, MODELS 1 AND 2. Classified as Cup, Menstrual (product code HHE), Class II - Special Controls.

Submitted by Lune Group , Ltd. (Madison, US). The FDA issued a Cleared decision on November 13, 2009 after a review of 150 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5400 - 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.

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Submission Details

510(k) Number K091754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date November 13, 2009
Days to Decision 150 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 160d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHE Cup, Menstrual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5400
Definition A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow.
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.