Cardiovascular · 510(k) · 2019
Loop System
Spry Health, Inc.. Cleared by FDA on 29 March 2019 under submission K181352, product code DQA (oximeter). What FDA's record says, in FDA's words.
Device record · K181352
- Device. Loop SystemDEVICE
- Company. Spry Health, Inc.COMPANY
- Decision. 29 March 2019, 510(k), substantially equivalent (traditional review); received 22 May 2018DECISION
- Panel. CardiovascularPANEL
- Product code. DQA, OximeterCODE
- Regulation. 21 CFR 870.2700, Class IIREG
- Source. FDA database entry · decision document (11 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.
The Loop System is intended for adult patients in the home environment for passive, non-invasive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician. The Loop System measures and records: • arterial oxygen saturation (SpO2) • heart rate (HR) • respiration rate (RR) All of these measurements are made when no motion is detected by the System. The Loop System device does not provide physiological alarms
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
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 14,142 reports filed against devices carrying product code DQA. 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 · EarlyVue VS30 · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102059
Philips received a complaint on the EarlyVue VS30 indicating that there was a speaker failure. The device was not in use on a patient at the time of the event, so there was no patient involvement.
30 September 2026 · Malfunction · Radical-7 · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00709
The customer reported there was a sudden drop in SpO2 readings. There was no patient impact or consequence reported.
30 September 2026 · Malfunction · EarlyVue VS30 · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102063
30 September 2026 · Malfunction · MEDLINE CO-LABEL · Medline ReNewal · report 3032391-2026-00242
29 September 2026 · Malfunction · O3 Module · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00703
The customer reported that the "Module measured high". There was no patient impact or consequence reported.
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 DQA, in Cardiovascular, or cleared in 2019. 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.