Cardiovascular · 510(k) · 2026
SafeBeat Rx App
SafeBeat Rx, Inc.. Cleared by FDA on 6 February 2026 under submission K251218, product code DQK (computer, diagnostic, programmable). What FDA's record says, in FDA's words.
Device record · K251218
- Device. SafeBeat Rx AppDEVICE
- Company. SafeBeat Rx, Inc.COMPANY
- Decision. 6 February 2026, 510(k), substantially equivalent (traditional review); received 21 April 2025DECISION
- Panel. CardiovascularPANEL
- Product code. DQK, Computer, Diagnostic, ProgrammableCODE
- Regulation. 21 CFR 870.1425, Class IIREG
- Source. FDA database entry · decision document (16 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.
Please type in the marketing application /submission number, if it is known. This K251218 ? textbox will be left blank for original applications /submissions . Please provide the device trade name(s). ? SafeBeat Rx App Please provide your Indications for Use below. ? The SafeBeat Rx App analyzes ECG data recorded in compatible formats. This ECG signal may originate from a full 12-lead ECG or a reduced lead set ECG. The device provides ECG signal processing and provisional analysis , including interval measurements (QT interval, QTc, ORS duration , heart rate, and RR interval), along with visible display of ORS onset (Q-start), R-peak, and ORS offset (S-end) . The SafeBeat Rx App can electronically interface with, and perform analysis of, data transferred from other computer- based ECG systems , such as an ECG management system . The SafeBeat Rx App does not provide real- time ECG display , continuous monitoring , or alarm functions . The device is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The SafeBeat Rx App ECG analysis is intended for adult patient populations (18 years and older ). SafeBeat Rx App provisional ECG analysis is not intended to be the sole means of diagnosis. The SafeBea Rx App is not validated for use in lead I alone. The SafeBeat Rx App is intended to be used on an advisory basis only by qualified healthcare personnel to evaluate provisional ECG data. ECG data should be reviewed in conjunction with the patient's […]
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.
- Modalities namedECG
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,558 reports filed against devices carrying product code DQK. 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. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · QUANTIEN · Abbott Medical · report 2184149-2026-00257
During a fractional flow reserve procedure with QUANTIEN, it was noted that the PA signals were not appearing on the monitor leading to the procedure being cancelled. There were no adverse patient consequences.
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18928
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18932
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18933
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18934
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 DQK, in Cardiovascular, or cleared in 2026. 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.