Cleared Traditional

Finger Pulse Oximeter, Model: X1906P (K221798) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 175
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