510(k) · Cleared
ClearedSheathes Ultrasond Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheathing Technologies, Inc. · MUI Media, Coupling, Ultrasound
Cleared on Jun 22, 2012 as substantially equivalent to K883917 (Sonomed Technology, Inc., 1989) and 1 other predicate after a 268-day review. Its family tree reaches back 2 generations to 1996. 1 of the 12 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Jun 22, 2012
- Review
- 268 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961757 (1996). 3 ancestors in all, the oldest K883917 (1989). 8 later devices descend from it, 3 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · Recalled (Class I)
- 1 generation backK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- This deviceK112827 Sheathes Ultrasond GelSheathing Technologies, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK130041 Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK181363 EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK131905 Solid Gel PadBluemtech · 2013
- Descendant · 2 generations on · 0 of its ownK252337 EdgeFlow Gel PadEdgecare, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK242167 Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Gel2 generations back · 1996
Most influential descendants
Showing 5 of 8 · See all- K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013 · cites it directly5descendants
- K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018 · cites it directly4descendants
- K131905Solid Gel PadBluemtech · 2013 · cites it directly1descendant
- K252337EdgeFlow Gel PadEdgecare, Inc. · 2026 · 2 generations on0descendants
- K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | Class I |
| −1 | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| 0 (this device) | K112827 | Sheathes Ultrasond Gel | Sheathing Technologies, Inc. | 2012 | — |
| +1 | K130041 | Sheathes Sterile Ultrasound Gel | Sheathing Technologies, Inc. | 2013 | — |
| +1 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | 2018 | — |
| +1 | K131905 | Solid Gel Pad | Bluemtech | 2013 | — |
| +2 | K252337 | EdgeFlow Gel Pad | Edgecare, Inc. | 2026 | — |
| +2 | K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K883917 | Natural Image Ultrasound Transmission CouplantSummary page 2…pulsed echo imaging system accessory Equivalence: Sonotech Natural Image Ultrasonic Couplant, 51 OK#K88391 7 Konix Ultrasound Gel, 510K#K101952 Labeling and Usage: The following information will be found… | 1989 |
| * | K101952 | Konix Ultrasound GelSummary page 2…y Equivalence: Sonotech Natural Image Ultrasonic Couplant, 51 OK#K88391 7 Konix Ultrasound Gel, 510K#K101952 Labeling and Usage: The following information will be found on each box/bag. (See Atachment E)… | 2011 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K130041 (Sheathing Technologies, Inc., 2013) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K883917.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112827: Sheathes Ultrasond Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112827
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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