Cleared Traditional

K781312 - THERMOMETER

K781312 is an FDA 510(k) clearance for THERMOMETER, manufactured by Yellow Springs Instrument Co., Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K781312 · Yellow Springs Instrument Co., Inc. · General Hospital
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Aug 1978
Decision
10d
Days
Class 2
Risk

K781312 is an FDA 510(k) clearance for the THERMOMETER, MODEL 49TA. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Yellow Springs Instrument Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 10 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Yellow Springs Instrument Co., Inc. devices

FDA 510(k) Submission Details - K781312

510(k) Number K781312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1978
Decision Date August 10, 1978
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
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 372
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K781312.
IVAC 833 ELECTRONIC THERMOMETER
K791208 · Y · Aug 1979
IVAC 819 ELECTRONIC THERMOMETER
K791209 · Y · Aug 1979
TEMPERATURE MODULE, DUAL
K781136 · Cavitron Corp. · Aug 1978
PROBE COVER
K780593 · Abco Dealers, Inc. · Jun 1978
TEMPERATURE MONITOR
K772217 · Hudson Oxygen Therapy Sales Co. · Dec 1977
ELECTROTHERM MODELS TC-100 & M-99
K771995 · Electromedics, Inc. · Nov 1977