Cleared Traditional

K945427 - B-D DIGITAL THERMOMETER (FDA 510(k) Clearance)

K945427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
223d
Days
-
Risk

K945427 is an FDA 510(k) clearance for the B-D DIGITAL THERMOMETER. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on June 15, 1995 after a review of 223 days - an extended review cycle.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K945427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1994
Decision Date June 15, 1995
Days to Decision 223 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
63d slower than avg
Panel avg: 160d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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