Cleared Traditional

K971994 - B-D ASSURE EAR THERMOMETER

K971994 is an FDA 510(k) clearance for B-D ASSURE EAR THERMOMETER, manufactured by Becton Dickinson Consumer Products. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K971994 · Becton Dickinson Consumer Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
337d
Days
Class 2
Risk

K971994 is an FDA 510(k) clearance for the B-D ASSURE EAR THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Becton Dickinson Consumer Products (Franklin Lake, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Becton Dickinson Consumer Products devices

FDA 510(k) Submission Details - K971994

510(k) Number K971994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date May 01, 1998
Days to Decision 337 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
208d slower than avg
Panel avg: 129d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

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 405
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K971994.
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
K981337 · Mesure Technology · Sep 1998
BABY PACIFIER DIGITAL THERMOMETER
K981456 · K-Jump Health Co., Ltd. · Jul 1998
QUICK CHECK INSTANT THERMOMETER
K971831 · Ejb Medical, Inc. · May 1998
FLEXIBLE TIP DIGITAL THERMOMETER
K974195 · K-Jump Health Co., Ltd. · Feb 1998
PRO CHECK DIGITAL PACIFIER THERMOMETER
K972259 · Micro Weiss Electronics · Jul 1997
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
K970011 · Medical Data Electronics · Jul 1997