Cleared Traditional

K220351 - Polso Watch

K220351 is an FDA 510(k) clearance for Polso Watch, manufactured by Chronisense Medical, Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K220351 · Chronisense Medical, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K220351

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.

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. 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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K220351.
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