Radiology · 510(k) · 2026
EdgeFlow UW20
Edgecare, Inc.. Cleared by FDA on 17 April 2026 under submission K252237, product code IYO (system, imaging, pulsed echo, ultrasonic). What FDA's record says, in FDA's words.
Device record · K252237
- Device. EdgeFlow UW20DEVICE
- Company. Edgecare, Inc. (KR)COMPANY
- Decision. 17 April 2026, 510(k), substantially equivalent (traditional review); received 17 July 2025DECISION
- Panel. RadiologyPANEL
- Product code. IYO, System, Imaging, Pulsed Echo, UltrasonicCODE
- Regulation. 21 CFR 892.1560, Class IIREG
- Source. FDA database entry · decision document (15 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 EdgeFlow UW20 is a wearable ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively in adult patients with BMI up to 30. The bladder volume measurements can be performed periodically at a set time interval set by the user. It is intended for use in professional healthcare facilities, such as hospitals and clinics, by qualified and trained healthcare professionals. The EdgeFlow UW20 supports B-mode and harmonic imaging modes.
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 namedultrasound
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 6,627 reports filed against devices carrying product code IYO. 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 · MEDLINE · Medline Industries, LP · report 1417592-2026-53998
It was reported that PRODUCT SCREEN COMES UP WITH ERROR CODE E005 BATTERY ERROR.
30 September 2026 · Injury · ViewFlex¿ICE Catheter · Abbott Medical · report 2030404-2026-00047
The following was published in the JACC: CASE REPORTS, "AIatrogenic VSD, Closure Attempt With Complications, and Ultimate Success", Jakob Schroder, MD, PHD, Niels Vejlstrup, MD, PHD, Laurence Campens, MD, PHD, Michael Rahbek Schmidt, MD, PHD, DMSC. VOL. 31, NO. 7, 202 6BACKGROUND Iatrogenic postsurgical ventricular septal defect (VSD) is a rare complication of surgical aortic valve replacement (SAVR). CASE SUMMARY A patient presented with left-sided heart failure due to an initially missed […]
30 September 2026 · Malfunction · MEDLINE CO-LABEL · Medline Industries, LP · report 1417592-2026-54811
30 September 2026 · Malfunction · MEDLINE CO-LABEL · Medline Industries, LP · report 1417592-2026-55041
30 September 2026 · Malfunction · Site~Rite 8 Scanner · C.R. Bard, Inc. (BASD) -3006260740 · report 3006260740-2026-07105
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 IYO, in Radiology, from Edgecare, Inc., 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.