Cardiovascular · 510(k) · 2021
CLEWICU System (ClewICUServer and ClewICUnitor)
CLEW Medical Ltd.. Cleared by FDA on 9 January 2021 under submission K200717, product code QNL (medium-term adjunctive predictive cardiovascular indicator). What FDA's record says, in FDA's words.
Device record · K200717
- Device. CLEWICU System (ClewICUServer and ClewICUnitor)DEVICE
- Company. CLEW Medical Ltd. (IL)COMPANY
- Decision. 9 January 2021, 510(k), substantially equivalent (traditional review); received 18 March 2020DECISION
- Panel. CardiovascularPANEL
- Product code. QNL, Medium-Term Adjunctive Predictive Cardiovascular IndicatorCODE
- Regulation. 21 CFR 870.2210, Class IIREG
- Source. FDA database entry · decision document (6 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
CLEWICU provides the clinician with physiological insight into a pati ent's li kelihood of future hemodynamic instability. CLEWICU is intended for use with intensive care unit (ICU) patients 18 years and over. CLEWICU is considered to provide addit ion al information regarding the patient's predicted future ri sk for clin ical deterioration, as well as identifying patients at low ri sk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the CLEWICU predictions.
The product code's definition, from FDA's classification record. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QNL. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QNL, in Cardiovascular, from CLEW Medical Ltd., or cleared in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.