Cleared Traditional

Pulse Oximeter (K220101) - FDA 510(k) Clearance

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

K220101 · Beijing Choice Electronic Technology Co., Ltd. · Anesthesiology device
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Mar 2023
Decision
420d
Days
Class 2
Risk

K220101 is an FDA 510(k) clearance for the Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on March 8, 2023 after a review of 420 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Beijing Choice Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K220101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2022
Decision Date March 08, 2023
Days to Decision 420 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
280d slower than avg
Panel avg: 140d · This submission: 420d
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 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K220101.
BabySat 3
K222597 · Owlet Babycare, Inc. · Jun 2023
Finger Pulse Oximeter, Model: X1906P
K221798 · Shenzhen Changkun Technology Co., Ltd. · May 2023
Masimo Rad-G with Temperature
K213676 · Masimo Corporation · Apr 2023
Handheld Pulse Oximeter
K213431 · Shenzhen Witleaf Medical Electronics Co., Ltd. · Feb 2023
Fingertip Pulse Oximeter
K213430 · Shenzhen Witleaf Medical Electronics Co., Ltd. · Dec 2022
Biobeat Platform-2 and BB-613WP Patch
K222010 · Biobeat Technologies , Ltd. · Dec 2022