Cleared Traditional

K935466 - CLINICAL VOICE THERMOMETER

K935466 is an FDA 510(k) clearance for CLINICAL VOICE THERMOMETER, manufactured by Blazie Engineering, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 517-day FDA review.

K935466 · Blazie Engineering, Inc. · General Hospital
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Apr 1995
Decision
517d
Days
Class 2
Risk

K935466 is an FDA 510(k) clearance for the CLINICAL VOICE THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Blazie Engineering, Inc. (Forest Hill, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 517 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Blazie Engineering, Inc. devices

FDA 510(k) Submission Details - K935466

510(k) Number K935466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1993
Decision Date April 13, 1995
Days to Decision 517 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
388d slower than avg
Panel avg: 129d · This submission: 517d
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 589
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K935466.
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
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
ELECTRONIC THERMOMETERS
K940686 · American Diagnostic Corp. · Jul 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
K934482 · Vital Signs, Inc. · May 1994