Cleared Traditional

K221798 - Finger Pulse Oximeter

K221798 is an FDA 510(k) clearance for Finger Pulse Oximeter, manufactured by Shenzhen Changkun Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K221798 · Shenzhen Changkun Technology Co., Ltd. · Anesthesiology device
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May 2023
Decision
317d
Days
Class 2
Risk

K221798 is an FDA 510(k) clearance for the Finger Pulse Oximeter, Model: X1906P. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Changkun Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 4, 2023 after a review of 317 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 Shenzhen Changkun Technology Co., Ltd. devices

FDA 510(k) Submission Details - K221798

510(k) Number K221798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2022
Decision Date May 04, 2023
Days to Decision 317 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 140d · This submission: 317d
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 K221798.
Pulse Oximeter
K230172 · Beijing Choice Electronic Technology Co., Ltd. · Aug 2023
Pulse Oximeter
K211143 · Shenzhen Brav Electronic Technologies Co., Ltd. · Jul 2023
BabySat 3
K222597 · Owlet Babycare, Inc. · Jun 2023
Masimo Rad-G with Temperature
K213676 · Masimo Corporation · Apr 2023
Pulse Oximeter
K220101 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2023
Handheld Pulse Oximeter
K213431 · Shenzhen Witleaf Medical Electronics Co., Ltd. · Feb 2023