Cleared Traditional

MEDI-AID BASAL THERMOMETER (K952756) - FDA 510(k) Clearance

K952756 · Polymedica Industries, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
101d
Days
-
Risk

K952756 is an FDA 510(k) clearance for the MEDI-AID BASAL THERMOMETER. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 101 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.

View all Polymedica Industries, Inc. devices

Submission Details

510(k) Number K952756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1995
Decision Date September 25, 1995
Days to Decision 101 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
59d faster than avg
Panel avg: 160d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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