Cleared Special

K070028 - CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER

K070028 is an FDA 510(k) clearance for CLASSIC/HYPOTHERMIA, manufactured by Actherm, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 36-day FDA review.

K070028 · Actherm, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
36d
Days
Class 2
Risk

K070028 is an FDA 510(k) clearance for the CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIG.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Actherm, Inc. (Jubei, Hsinchu, TW). The FDA issued a Cleared decision on February 8, 2007 after a review of 36 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070028

510(k) Number K070028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date February 08, 2007
Days to Decision 36 days
Submission Type Special
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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 697
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K070028.
WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
K063542 · Mesure Technology Co., Ltd. · Apr 2007
CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
K070342 · American I.V. Products, Inc. · Mar 2007
MONITORING EAR THERMOMETER, MODEL BTM-D1A
K062445 · Rio Flexon Technology Co., Ltd. · Feb 2007
ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · ACON Laboratories, Inc. · Feb 2007
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1
K062867 · Microlife Intellectual Property GmbH · Dec 2006
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
K063291 · Choice Smart Health Care Co. , Ltd. · Nov 2006
K070028 · CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
Download PDF FDA Summary Actherm, Inc.