Cleared Traditional

DUOFERTILITY (K102499) - FDA 510(k) Clearance

K102499 · Cambridge Temperature Concepts , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
476d
Days
-
Risk

K102499 is an FDA 510(k) clearance for the DUOFERTILITY. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Cambridge Temperature Concepts , Ltd. (Cambridge, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 476 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Cambridge Temperature Concepts , Ltd. devices

Submission Details

510(k) Number K102499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2010
Decision Date December 20, 2011
Days to Decision 476 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
316d slower than avg
Panel avg: 160d · This submission: 476d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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