Cleared Traditional

K070878 - DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300

K070878 is an FDA 510(k) clearance for DATATHERM II CONTINUOUS TEMPERATURE MONITOR, manufactured by Rg Medical Diagnostics. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K070878 · Rg Medical Diagnostics · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
68d
Days
Class 2
Risk

K070878 is an FDA 510(k) clearance for the DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Rg Medical Diagnostics (Southfield, US). The FDA issued a Cleared decision on June 5, 2007 after a review of 68 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.

FDA 510(k) Submission Details - K070878

510(k) Number K070878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2007
Decision Date June 05, 2007
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 777
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K070878.
MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
K072108 · Tecnimed S.R.L. · Aug 2007
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER
K070578 · Zen Strong Medical Technology Co., Ltd. · Jul 2007
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K070491 · K-Jump Health Co., Ltd. · Jun 2007
SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)
K062784 · Sejoy Electronics & Instruments Co., Ltd. · May 2007
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
K071019 · Mesure Technology Co., Ltd. · Apr 2007
RII INFRARED EAR THERMOMETER, MODEL TH01BN
K070976 · Radiant Innovation, Inc. · Apr 2007
K070878 · DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
Download PDF FDA Summary Rg Medical Diagnostics