Cleared Traditional

K182751 - Reusable Temperature Probe

K182751 is the FDA 510(k) clearance for Reusable Temperature Probe by Shenzhen Caremed Medical Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K182751 · Shenzhen Caremed Medical Technology Co., Ltd. · General Hospital
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Sep 2019
Decision
343d
Days
Class 2
Risk

K182751 is an FDA 510(k) clearance for the Reusable Temperature Probe. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen Caremed Medical Technology Co., Ltd. (Dalang Office, Longhua District, Shenzhe, CN). The FDA issued a Cleared decision on September 6, 2019 after a review of 343 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Caremed Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K182751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date September 06, 2019
Days to Decision 343 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
214d slower than avg
Panel avg: 129d · This submission: 343d
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

Chonconn Medical Device Consulting Co., Ltd.
Kevin Wang

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 317
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