510(k) · Cleared
ClearedKonix Ultrasound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · ITX Transducer, Ultrasonic, Diagnostic
Cleared on May 27, 2011 as substantially equivalent to K961757 (Eco-Med Pharmaceuticals, Inc., 1996) after a 319-day review. Its family tree reaches back 1 generation to 1996. 1 of the 18 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- May 27, 2011
- Review
- 319 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961757 (1996). 16 later devices descend from it, 3 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · Recalled (Class I)
- This deviceK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- Descendant · cites it directly · 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 · 2 generations on · 5 of its ownK130041 Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK181363 EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK163026 Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Geldirect predicate · 1996
Most influential descendants
Showing 5 of 16 · See all- K112827Sheathes Ultrasond GelSheathing Technologies, Inc. · 2012 · cites it directly8descendants
- K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical · 2016 · cites it directly5descendants
- K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013 · 2 generations on5descendants
- K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018 · 2 generations on4descendants
- K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | Class I |
| 0 (this device) | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| +1 | K112827 | Sheathes Ultrasond Gel | Sheathing Technologies, Inc. | 2012 | — |
| +1 | K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | 2016 | — |
| +2 | K130041 | Sheathes Sterile Ultrasound Gel | Sheathing Technologies, Inc. | 2013 | — |
| +2 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | 2018 | — |
| +2 | K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (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 |
|---|---|---|---|
| * | K961757 | Ecogel 100 Ultrasound GelSummary page 2…sonic transducer/acoustic gel (21 CFR § 892.1570, Product code ITX) Predicate device Eco-Med Pharmaceuticals' Ecogel 100 Ultrasound Gel (K961757) Device description Konix® Ultrasound Gel consists of deionized water, carbomer, triethanolamine, monopropylene glycol,… | 1996 |
What descends from it? (16)
See all 163 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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Konix® Ultrasound Gel is intended for general use as a nonsterile transmission media for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101952: Konix Ultrasound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101952
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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