Cleared Traditional

MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET (K852194) - FDA 510(k) Clearance

K852194 · Sharp Electronics Corp. · Obstetrics & Gynecology device
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Sep 1985
Decision
130d
Days
-
Risk

K852194 is an FDA 510(k) clearance for the MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Sharp Electronics Corp. (Paramus, US). The FDA issued a Cleared decision on September 27, 1985 after a review of 130 days - within the typical 510(k) review window.

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. 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 K852194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date September 27, 1985
Days to Decision 130 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 160d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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