Cleared Traditional

K203636 - PlusCare Temperature Probes

Also marketed or referenced as:
Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG

K203636 is an FDA 510(k) clearance for PlusCare Temperature Probes, manufactured by Jkh USA, LLC. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K203636 · Jkh USA, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
260d
Days
Class 2
Risk

K203636 is an FDA 510(k) clearance for the PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Jkh USA, LLC (Walnut, US). The FDA issued a Cleared decision on August 31, 2021 after a review of 260 days - an extended review cycle.

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 Jkh USA, LLC devices

FDA 510(k) Submission Details - K203636

510(k) Number K203636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2020
Decision Date August 31, 2021
Days to Decision 260 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
131d slower than avg
Panel avg: 129d · This submission: 260d
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 362
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K203636.
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · Longnan Renzhong Medical Equipment Co., Ltd. · Sep 2021
Electronic Thermometer (XHF2001, XHF2002)
K211352 · Putian Hanjiang Huafeng Plastic Co., Ltd. · Sep 2021
Infrared Thermometer, Model: HW-1
K211583 · Dongguan Simzo Electronic Technology Co., Ltd. · Sep 2021
Sensatronic Reusable Temperature Probes
K203643 · Sensatronic GmbH · Aug 2021
Disposable Ear Thermometer Probe Cover
K203431 · Huaian Zhongxin Packing Material Co., Ltd. · Jul 2021
Infrared Forehead Thermometer, Model BSX976
K202296 · Shenzhen Bsx Technology Electronics Co., Ltd. · Jul 2021