Cleared Traditional

K935267 - B-D DIGITAL THERMOMETER

K935267 is the FDA 510(k) clearance for B-D DIGITAL THERMOMETER by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
288d
Days
Class 2
Risk

K935267 is an FDA 510(k) clearance for the B-D DIGITAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 288 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. 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 General Hospital 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 K935267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date August 17, 1994
Days to Decision 288 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 129d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 332
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K935267.
R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247
K951402 · R & D Batteries, Inc. · Aug 1995
R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650
K951403 · R & D Batteries, Inc. · Aug 1995
R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131
K951404 · R & D Batteries, Inc. · Aug 1995
ELECTRONIC THERMOMETERS
K940686 · American Diagnostic Corp. · Jul 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
K934482 · Vital Signs, Inc. · May 1994
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
K925792 · Deroyal Industries, Inc. · Apr 1994