510(k) · Cleared
Recalled · Class I · 2021Ecogel 100 Ultrasound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eco-Med Pharmaceuticals, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 25, 1996 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 18 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jul 25, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 2 (2 Class I)
- Predicates
- 0
17 later devices descend from it, 4 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- This deviceK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996
- Descendant · cites it directly · 16 of its ownK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- Descendant · 2 generations on · 8 of its ownK112827 Sheathes Ultrasond GelSheathing Technologies, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK151070 Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical · 2016
- Descendant · 3 generations on · 5 of its ownK130041 Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK181363 EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K101952Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011 · cites it directly16descendants
- K112827Sheathes Ultrasond GelSheathing Technologies, Inc. · 2012 · 2 generations on8descendants
- K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical · 2016 · cites it directly5descendants
- K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013 · 3 generations on5descendants
- K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | — |
| +1 | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| +2 | K112827 | Sheathes Ultrasond Gel | Sheathing Technologies, Inc. | 2012 | — |
| +1 | K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | 2016 | — |
| +3 | K130041 | Sheathes Sterile Ultrasound Gel | Sheathing Technologies, Inc. | 2013 | — |
| +3 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (17)
See all 174 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2021 | Class I | Z-2480-2021 | Process control | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Aug 11, 2021 | Class I | Z-0090-2022 | Process control | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101952 (Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa, 2011) has gone furthest, with 16 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
https://510kreport.com/device/K961757 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961757: Ecogel 100 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/K961757
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026