Cleared Traditional

Polso Watch (K220351) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K220351 · Chronisense Medical, Ltd. · Anesthesiology device
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Nov 2022
Decision
284d
Days
Class 2
Risk

K220351 is an FDA 510(k) clearance for the Polso Watch. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Chronisense Medical, Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on November 18, 2022 after a review of 284 days - an extended review cycle.

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. Standard predicate reliance. 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 Chronisense Medical, Ltd. devices

Submission Details

510(k) Number K220351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2022
Decision Date November 18, 2022
Days to Decision 284 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
144d slower than avg
Panel avg: 140d · This submission: 284d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

RQM+
Allison Komiyama

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.

Clinical Evidence

ClinicalTrials.gov
NCT03735329 Completed Interventional Industry-sponsored

Polso SpO2 Accuracy Validation Study

10
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Hypoxia
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Arthur Cabrera, MD
Sponsor ChroniSense Medical Ltd. (industry)
Started 2019-01-29 → Primary completion 2019-01-31 → Completed 2019-02-04
Primary outcome
SpO2 percentage
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 175
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K220351.
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
Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
K213984 · Shenzhen Zhengkang Technology Co., Ltd. · Dec 2022
Empatica Health Monitoring Platform
K221282 · Empatica S.R.L. · 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
YUWELL Finger Pulse Oximeter
K212385 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Aug 2022