Cleared Traditional

K213100 - FMT Reusable Temperature Probes (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213100 · Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
662d
Days
Class 2
Risk

K213100 is an FDA 510(k) clearance for the FMT Reusable Temperature Probes. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti (Yenimahalle - Ankara, TR). The FDA issued a Cleared decision on July 18, 2023 after a review of 662 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.

View all Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti devices

Submission Details

510(k) Number K213100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date July 18, 2023
Days to Decision 662 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
534d slower than avg
Panel avg: 128d · This submission: 662d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Arazy Group Consultants, Inc.
Ray Kelly

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 796
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K213100.
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
K251160 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 2026
Ear Thermometer (EAR-E101)
K250470 · Shenzhen AOJ Medical Technology Co., Ltd. · Jun 2025
Reusable Temperature Probe (T1306, T2306, T3306, T4306)
K243000 · Shenzhen Medke Technology Co., Ltd. · Jun 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · May 2025
Infrared Thermometer
K243082 · Guangzhou Daxin Health Technology Co., Ltd. · Apr 2025
AION TempShield™
K250401 · Aion Biosystems, Inc. · Mar 2025