510(k) · Cleared
ClearedSolid Gel Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluemtech · MUI Media, Coupling, Ultrasound
Cleared on Jul 18, 2013 as substantially equivalent to K112827 (Sheathing Technologies, Inc., 2012) and 1 other predicate after a 22-day review. Its family tree reaches back 3 generations to 1996. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 18, 2013
- Review
- 22 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961757 (1996). 6 ancestors in all, the oldest K802146 (1980). 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · Recalled (Class I)
- 2 generations backK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- 1 generation backK112827 Sheathes Ultrasond GelSheathing Technologies, Inc. · 2012
- This deviceK131905 Solid Gel PadBluemtech · 2013
- Descendant · cites it directly · 0 of its ownK252337 EdgeFlow Gel PadEdgecare, Inc. · 2026
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Gel3 generations back · 1996
Most influential descendants
Showing 1 of 1 · See all- K252337EdgeFlow Gel PadEdgecare, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | Class I |
| −2 | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| −1 | K112827 | Sheathes Ultrasond Gel | Sheathing Technologies, Inc. | 2012 | — |
| 0 (this device) | K131905 | Solid Gel Pad | Bluemtech | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K112827 | Sheathes Ultrasond GelSummary page 2…viscosity index of crude oil and petroleum products 8. Substantial Equivalence The SOLID GEL PAD is substantially equivalent to the Sheathes Ultrasound Gel (KI 112827) and Thixo-Gel Ultrasound Spray (K12131 I). They all are water based gel, but some compositions are different among the… | 2012 |
| * | K121311 | Thixo-Gel Ultrasound SpraySummary page 1…tion Product Code: MUI 4. Predicate Device: Sheathes Ultrasound Gel (KI 12827) by Sheathing Technologies, Inc Thixo-Gel Ultrasound Spray (K12131 1) by Christina Bernstein BB Medical Surgical, Inc. 5. Device Description: The SOLID GEL PAD is ultrasouind gel of… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252337 | EdgeFlow Gel Pad | 2026 | 0 |
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 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252337 (Edgecare, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112827.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131905: Solid Gel Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131905
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026