Cleared Traditional

K212385 - YUWELL Finger Pulse Oximeter

K212385 is an FDA 510(k) clearance for YUWELL Finger Pulse Oximeter, manufactured by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K212385 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
379d
Days
Class 2
Risk

K212385 is an FDA 510(k) clearance for the YUWELL Finger Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on August 16, 2022 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. devices

FDA 510(k) Submission Details - K212385

510(k) Number K212385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2021
Decision Date August 16, 2022
Days to Decision 379 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 140d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K212385.
Polso Watch
K220351 · Chronisense Medical, Ltd. · Nov 2022
Oxyfit Pulse Oximeter
K203812 · Shenzhen Viatom Technology Co., Ltd. · Nov 2022
Pulse Oximeter (Model C101A2, C101B1, C101A3)
K221979 · Shenzhen Imdk Medical Technology Co., Ltd. · Oct 2022
Masimo CARESCAPE SpO2 – Masimo with SpHb
K221953 · Masimo Corporation · Aug 2022
Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)
K212665 · Huizhou Xiaoou Technology Co., Ltd. · Jun 2022
Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
K203208 · Taiwan Aulisa Medical Devices Technologies, Inc. · Jun 2022