Cleared Traditional

K962520 - DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A

K962520 is an FDA 510(k) clearance for DIGITAL CLINICAL THERMOMETER ST-813A, manufactured by Mesure Technology. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K962520 · Mesure Technology · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
77d
Days
Class 2
Risk

K962520 is an FDA 510(k) clearance for the DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mesure Technology (Mission Viejo, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 77 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 Mesure Technology devices

FDA 510(k) Submission Details - K962520

510(k) Number K962520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1996
Decision Date September 12, 1996
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 406
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K962520.
ENTRACARE THERMOMTER MODEL 1000
K964851 · Entracare Corp. · Feb 1997
SURETEMP
K964643 · Diatek Instruments, Inc. · Jan 1997
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
K955846 · Y · Oct 1996
BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
K962991 · Polymedica Industries, Inc. · Sep 1996
ENDOCARE ELECTORNIC THERMOMETER SYSTEM
K961365 · Endocare, Inc. · Aug 1996
YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
K962070 · Yellow Springs Instrument Co., Inc. · Jul 1996