Cleared Traditional

K945427 - B-D DIGITAL THERMOMETER

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

FDA 510(k) Submission Details - K945427

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 160d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

LHD Device Classification - Class 0,

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