510(k) · Cleared
ClearedEdgeFlow Gel Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edgecare, Inc. · MUI Media, Coupling, Ultrasound
Cleared on Apr 24, 2026 as substantially equivalent to K131905 (Bluemtech, 2013) after a 270-day review. Its family tree reaches back 4 generations to 1996. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 24, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961757 (1996). 7 ancestors in all, the oldest K802146 (1980). No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · Recalled (Class I)
- 3 generations backK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- 2 generations backK112827 Sheathes Ultrasond GelSheathing Technologies, Inc. · 2012
- 1 generation backK131905 Solid Gel PadBluemtech · 2013
- This deviceK252337 EdgeFlow Gel PadEdgecare, Inc. · 2026
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Gel4 generations back · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | Class I |
| −3 | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| −2 | K112827 | Sheathes Ultrasond Gel | Sheathing Technologies, Inc. | 2012 | — |
| −1 | K131905 | Solid Gel Pad | Bluemtech | 2013 | — |
| 0 (this device) | K252337 | EdgeFlow Gel Pad | Edgecare, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUI device
- #1 K253255 Non-Sterile Ultrasound Gel Sterile Ultrasound…score 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131905 | Solid Gel PadSummary page 6…assification Panel: Radiology 1 3. Predicate Device • Primary Predicate Device: SOLID GEL PAD (K131905), BLUEMTECH • Reference Device: AQUASONIC 100 Ultrasound Gel (K802146), PARKER LABORATORIES 4. Subject Device Descriptio… | 2013 |
| † | K802146 | Aquasonic 100 Ultrasound Trans. Gel, | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K961757Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 12.8 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MUI
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MUI
434in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUI
25in 2025
MAUDE reports naming product code MUI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 2 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 434 | 0 | 2 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 1 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EdgeFlow Gel Pad is a non-sterile, single-use accessory intended for use exclusively with the EdgeFlow UW20 wearable bladder scanner. The device provides acoustic coupling between the ultrasound transducer and the patient’s intact abdominal skin during bladder ultrasound procedures, enabling transmission of ultrasound signals required for bladder imaging and bladder volume measurement. It is intended for use in professional healthcare facilities, such as hospitals and clinics, by qualified and trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252337 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252337: EdgeFlow Gel Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252337
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026