Cleared Traditional

K120671 - DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)

K120671 is an FDA 510(k) clearance for DIGITAL PACIFIER THERMOMETER (MODEL NO...., manufactured by Cotronic Technology Limited. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 438-day FDA review.

K120671 · Cotronic Technology Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
438d
Days
Class 2
Risk

K120671 is an FDA 510(k) clearance for the DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Cotronic Technology Limited (Shen Zhen, Guang Dong, CN). The FDA issued a Cleared decision on May 17, 2013 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K120671

510(k) Number K120671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2012
Decision Date May 17, 2013
Days to Decision 438 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
309d slower than avg
Panel avg: 129d · This submission: 438d
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 679
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K120671.
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VISIOFOCUS
K122412 · Tecnimed S.R.L. · Mar 2013
K120671 · DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
Download PDF FDA Summary Cotronic Technology L…