Cleared Traditional

K952756 - MEDI-AID BASAL THERMOMETER

K952756 · Polymedica Industries, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K952756

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 161d · This submission: 101d
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

All 9
Devices cleared under the same product code (LHD) and FDA review panel - the closest regulatory comparables to K952756.
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
K030961 · Microlife Corp. · Sep 2003
PETIT SOPHIA
K021978 · Nishitomo Co., Inc. · Apr 2003
TCOYF FERTILITY SOFTWARE VERSION 1.0
K002726 · Ovusoft, LLC · Apr 2001
B-D DIGITAL THERMOMETER
K945427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1995
L SOPHIA
K901512 · Nishitomo Co., Inc. · Jul 1990
K952756 · MEDI-AID BASAL THERMOMETER
Download PDF FDA Summary Polymedica Industries…