Cleared Traditional

Probe Covers (YF-001, YF-002) (K240023) - FDA 510(k) Clearance

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

K240023 · Shenzhen YI Fang Blister Packaging Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
58d
Days
Class 2
Risk

K240023 is an FDA 510(k) clearance for the Probe Covers (YF-001, YF-002). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen YI Fang Blister Packaging Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 1, 2024 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen YI Fang Blister Packaging Co., Ltd. devices

Submission Details

510(k) Number K240023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2024
Decision Date March 01, 2024
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 Peers - FLL Continuous Measurement Thermometer

All 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K240023.
Medical electronic thermometer (FC01, FC02)
K240109 · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Apr 2024
Wireless Smart Thermometer
K233192 · Famidoc Technology Company Limited · Apr 2024
Digital Thermometer
K230889 · Wenzhou Yosun Medical Technology Co.,Ltd · Apr 2024
Infrared Thermometer: Model YJ600
K232473 · Zhuhai Yueja Medical Device Technology Co., Ltd. · Feb 2024
VitalDetect
K231625 · Wellvii, Inc. · Feb 2024
Digital Thermometer, Model T28, T28L
K232678 · Guangdong Genial Technology Co., Ltd. · Jan 2024