Cleared Traditional

K122337 - OVUSENSE

K122337 · Fertility Focus, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
369d
Days
-
Risk

K122337 is an FDA 510(k) clearance for the OVUSENSE. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Fertility Focus, Ltd. (Swanee, US). The FDA issued a Cleared decision on August 6, 2013 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel. 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. Elevated predicate reliance profile. 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 - K122337

510(k) Number K122337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2012
Decision Date August 06, 2013
Days to Decision 369 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 161d · This submission: 369d
Pathway characteristics
Predicate-based equivalence.

LHD Device Classification - Class 0,

Product Code LHD Device, Fertility Diagnostic, Proceptive
Device Class -

Regulatory Peers - LHD Device, Fertility Diagnostic, Proceptive

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