Cleared Traditional

Handheld Pulse Oximeter (K213431) - FDA 510(k) Clearance

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

K213431 · Shenzhen Witleaf Medical Electronics Co., Ltd. · Anesthesiology device
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Feb 2023
Decision
493d
Days
Class 2
Risk

K213431 is an FDA 510(k) clearance for the Handheld Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Witleaf Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 26, 2023 after a review of 493 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 Shenzhen Witleaf Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K213431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2021
Decision Date February 26, 2023
Days to Decision 493 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
353d slower than avg
Panel avg: 140d · This submission: 493d
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 Consultant

Chonconn Medical Device Consulting Co., Ltd.
Kevin Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K213431.
Finger Pulse Oximeter, Model: X1906P
K221798 · Shenzhen Changkun Technology Co., Ltd. · May 2023
Masimo Rad-G with Temperature
K213676 · Masimo Corporation · Apr 2023
Pulse Oximeter
K220101 · Beijing Choice Electronic Technology Co., Ltd. · Mar 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
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
K222213 · Unimed Medical Supplies, Inc. · Dec 2022