Cleared Traditional

Electronic Thermometer (XHF2001, XHF2002) (K211352) - FDA 510(k) Clearance

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

K211352 · Putian Hanjiang Huafeng Plastic Co., Ltd. · General Hospital
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Sep 2021
Decision
129d
Days
Class 2
Risk

K211352 is an FDA 510(k) clearance for the Electronic Thermometer (XHF2001, XHF2002). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Putian Hanjiang Huafeng Plastic Co., Ltd. (Putian, CN). The FDA issued a Cleared decision on September 9, 2021 after a review of 129 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Putian Hanjiang Huafeng Plastic Co., Ltd. devices

Submission Details

510(k) Number K211352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date September 09, 2021
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray 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 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K211352.
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
K203662 · Yibin Junxin Electronics Technology Co., Ltd. · Sep 2021
Medline Digital Thermometer Non-Lubricated Probe Sheath
K211931 · Medline Industries, Inc. · Sep 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · Longnan Renzhong Medical Equipment Co., Ltd. · Sep 2021
Infrared Thermometer, Model: HW-1
K211583 · Dongguan Simzo Electronic Technology Co., Ltd. · Sep 2021
PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS
K203636 · Jkh USA, LLC · Aug 2021
Sensatronic Reusable Temperature Probes
K203643 · Sensatronic GmbH · Aug 2021