510(k) · Cleared
ClearedSheathes Sterile Ultrasound 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 Feb 6, 2013 as substantially equivalent to K931909 (Sonomed Technology, Inc., 1994) and 2 other predicates after a 29-day review. Its family tree reaches back 3 generations to 1996. 1 of the 12 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Feb 6, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K961757 (1996). 6 ancestors in all, the oldest K883917 (1989). 5 later devices descend from it, 1 citing it directly. 1 of the 12 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 deviceK130041 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 · 2 generations on · 0 of its ownK242167 Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK241789 Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK232957 Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK221999 Ultrasound Transmission GelsHony Medical Co., Ltd. · 2022
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Gel3 generations back · 1996
Most influential descendants
Showing 5 of 5 · See all- K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018 · cites it directly4descendants
- K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
- K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd. · 2024 · 2 generations on0descendants
- K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd. · 2023 · 2 generations on0descendants
- K221999Ultrasound Transmission GelsHony Medical Co., Ltd. · 2022 · 2 generations on0descendants
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) | K130041 | Sheathes Sterile Ultrasound Gel | Sheathing Technologies, Inc. | 2013 | — |
| +1 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | 2018 | — |
| +2 | K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | 2024 | — |
| +2 | K241789 | Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. | 2024 | — |
| +2 | K232957 | Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. | 2023 | — |
| +2 | K221999 | Ultrasound Transmission Gels | Hony Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K931909 | Clear Image Sterile Diagnostic Ultrsound GelSummary page 2…ame: Ultrasonic pulsed echo imaging system I accessory Equivalence: Sonotech Clear Image TM Sterile Scanning Gel, K931 909 Sheathing Technologies Ultrasound Gel, K1 12827 Sonotech Ult… | 1994 |
| * | K112827 | Sheathes Ultrasond GelSummary page 2…Sonotech Clear Image TM Sterile Scanning Gel, K931 909 Sheathing Technologies Ultrasound Gel, K1 12827 Sonotech UltraBioTM Sterile Ultrasound Imaging Couplant, K642619. Labeling and Usa… | 2012 |
| * | K042619 | Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging CouplantSummary page 3…s's Ultrasound Gel, K1 12827, and to Sonotech/Sonomed's UltraBlo Sterile Ultrasound Imaging Couplant, K04261 9. Non-Clinical Tests: 1. Biocompatibility a. Cytot… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | 2018 | 4 |
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 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K181363 (H R Pharmaceuticals, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K931909.
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?
Sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended for non-invasive use in 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/K130041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130041: Sheathes Sterile Ultrasound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130041
Report an extraction error
Are you the manufacturer?
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