Cleared Special

K130361 - THERMOFINDER

Also marketed or referenced as:
THERMOCARE

K130361 is an FDA 510(k) clearance for THERMOFINDER, manufactured by Hubdic Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 48-day FDA review.

K130361 · Hubdic Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
48d
Days
Class 2
Risk

K130361 is an FDA 510(k) clearance for the THERMOFINDER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Hubdic Co., Ltd. (Canonsburg, US). The FDA issued a Cleared decision on April 2, 2013 after a review of 48 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.

View all Hubdic Co., Ltd. devices

FDA 510(k) Submission Details - K130361

510(k) Number K130361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2013
Decision Date April 02, 2013
Days to Decision 48 days
Submission Type Special
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
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Modification to existing cleared device. 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

Pharmalink Technical Group, LLC

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 528
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K130361.
CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
K131771 · Thermomedics, Inc. · Oct 2013
UGFT3
K131155 · Medisim, Ltd. · Aug 2013
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
K120671 · Cotronic Technology Limited · May 2013
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · Taidoc Technology Corporation · Mar 2013
VISIOFOCUS
K122412 · Tecnimed S.R.L. · Mar 2013
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
K121999 · Draeger Medical GmbH · Feb 2013