K222010 is an FDA 510(k) clearance for the Biobeat Platform-2 and BB-613WP Patch. Classified as Oximeter (product code DQA), Class II - Special Controls.
Submitted by Biobeat Technologies , Ltd. (Petah Tikvah, IL). The FDA issued a Cleared decision on December 30, 2022 after a review of 176 days - an extended review cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Biobeat Technologies , Ltd. devices
NCT04955184
Completed
Observational
Industry-sponsored
Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter
Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter During Ambulatory Assessment of CHF Patients
| Condition studied |
Cardiac Output, Low; Cardiac Output, High; Congestive Heart Failure |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Dean Nachman, MD |
| Sponsor |
Biobeat Technologies Ltd.
(industry)
|
Started 2021-10-10
→
Primary completion 2022-06-15
→
Completed 2022-06-25
Primary outcome
Comparison of cardiac output obtained by a non-unvasive device to the invasive method
Study completed - no results published.
This trial concluded in 2022 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510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov