510(k) · Cleared
ClearedNon-Sterile Ultrasound Gel Sterile Ultrasound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Pingchuang Medical Technology Co., Ltd. · MUI Media, Coupling, Ultrasound
Cleared on Jun 17, 2026 as substantially equivalent to K163026 (Pharmaceutical Innovations, Inc., 2018) after a 261-day review. Its family tree reaches back 4 generations to 1996. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 17, 2026
- Review
- 261 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961757 (1996). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · Recalled (Class I)
- 3 generations backK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- 2 generations backK151070 Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical · 2016
- 1 generation backK163026 Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. · 2018
- This deviceK253255 Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd. · 2026
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Gel2 generations back · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | Class I |
| −3 | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| −2 | K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | 2016 | — |
| −1 | K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | 2018 | — |
| 0 (this device) | K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. | 2026 | — |
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 K252337 EdgeFlow Gel Padscore 12.1 · 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? (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 |
|---|---|---|---|
| * | K163026 | Ultra/Phonic Scanning GelSummary page 5…ted Predicate Device Trade Name Ultra/Phonic® Scanning Gel Manufacturer Pharmaceutical Innovations, Inc. 510(k) Number K163026 Product Code MUI Device Class II Regulation No. 21 CFR 892.1570 The predicate dev… | 2018 |
| † | K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Gel is intended to be used on intact skin as a non-sterile transmission media for coupling sound waves between a patient and the ultrasound transducer during non-invasive diagnostic ultrasound imaging procedures.
Sterile Ultrasound Gel is intended to be used on intact skin as a sterile transmission media for coupling sound waves between a patient and the ultrasound transducer during non-invasive diagnostic ultrasound imaging procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253255: Non-Sterile Ultrasound Gel Sterile 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/K253255
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026