510(k) · Cleared
ClearedEnvision ultrasound pad and cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civco Medical Solutions · ITX Transducer, Ultrasonic, Diagnostic
Cleared on May 24, 2019 after a 56-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- May 24, 2019
- Review
- 56 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 2 citing it directly.
- This deviceK190802 Envision ultrasound pad and coverCivco Medical Solutions · 2019
- Descendant · cites it directly · 1 of its ownK211270 CIV-Clear coverCIVCO Medical Instruments Co., Inc. · 2021
- Descendant · cites it directly · 0 of its ownK260114 Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241662 Ultrasound Transducer CoverVitrolife Sweden AB · 2024
Most influential descendants
Showing 3 of 3 · See all- K211270CIV-Clear coverCIVCO Medical Instruments Co., Inc. · 2021 · cites it directly1descendant
- K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026 · cites it directly0descendants
- K241662Ultrasound Transducer CoverVitrolife Sweden AB · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190802 | Envision ultrasound pad and cover | Civco Medical Solutions | 2019 | — |
| +1 | K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | 2021 | — |
| +1 | K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026 | — |
| +2 | K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 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.
Planning a device in ITX? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K750680 | General Purpose Transducer Cover Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211270 (CIVCO Medical Instruments Co., Inc., 2021) has gone furthest, with 1 descendant 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. 2019, 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?
The Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging electronics.
The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile and non-sterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190802: Envision ultrasound pad and cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190802
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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