Cleared Traditional

K081162 - TEMPTOUCH DERMAL THERMOMETER

K081162 is an FDA 510(k) clearance for TEMPTOUCH DERMAL THERMOMETER, manufactured by Diabetica Solutions, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K081162 · Diabetica Solutions, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
14d
Days
Class 2
Risk

K081162 is an FDA 510(k) clearance for the TEMPTOUCH DERMAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Diabetica Solutions, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 8, 2008 after a review of 14 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 - K081162

510(k) Number K081162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2008
Decision Date May 08, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 697
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K081162.
AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
K081160 · Avita Corporation · Jun 2008
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
K081256 · Rio Flexon Technology Co., Ltd. · May 2008
THERMOFLASH LX-26
K080759 · Jxb Co. Ltd Guangzhou (China) · May 2008
EAR THERMOMETER, MODELS ST66 AND ST67
K080981 · Mesure Technology Co., Ltd. · May 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · Taidoc Technology Corporation · Apr 2008
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
K073366 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2008

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K081162 · TEMPTOUCH DERMAL THERMOMETER
Download PDF FDA Summary Diabetica Solutions, …