K212143 is an FDA 510(k) clearance for the Neteera 130H/131H Vital Sign Monitoring Sensor. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.
Submitted by Neteera Technologies , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on September 28, 2022 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: 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 Cardiovascular submissions.
View all Neteera Technologies , Ltd. devices
NCT04796181
Completed
Observational
Industry-sponsored
Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device
Single Center, Single Blinded, Prospective Validation Study for the Accuracy and Safety Evaluation of Neteera 130H, a Novel, Radar-based Contact-free Device for Heart and Respiratory Rate Measurements
| Condition studied |
Healthy Subjects; Chronic Conditions, Multiple |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Todd Bertoch, MD |
| Sponsor |
Neteera Technologies Ltd.
(industry)
|
Started 2021-02-21
→
Primary completion 2022-03-25
→
Completed 2022-07-02
Primary outcome
Proportion of accurate spot HR while the Neteera 130H located behind the subject.
Secondary outcome
Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.
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510(k) Summary PDF or remain unpublished.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