510(k) · Cleared
ClearedTransducer Probe Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hony Medical Co., Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jan 11, 2023 as substantially equivalent to K970513 (CIVCO Medical Instruments Co., Inc., 1997) after a 253-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Jan 11, 2023
- Review
- 253 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844472 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK844472 Civco Scan DrapeCIVCO Medical Instruments Co., Inc. · 1985
- 1 generation backK970513 General Purpose Tranducer CoverCIVCO Medical Instruments Co., Inc. · 1997
- This deviceK221278 Transducer Probe CoverHony Medical Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK233965 UltraDrape UGPIV Barrier and Securement (34-15)Parker Laboratories, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK241615 Transducer Probe CoverHony Medical Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844472 | Civco Scan Drape | CIVCO Medical Instruments Co., Inc. | 1985 | — |
| −1 | K970513 | General Purpose Tranducer Cover | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| 0 (this device) | K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023 | — |
| +1 | K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024 | — |
| +1 | K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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.
What descends from it? (2)
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?
- The line of descent spans 38 years and passes through 2 companies; a new generation was cleared every 25.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233965 (Parker Laboratories, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K970513.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for external intact skin diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221278: Transducer Probe Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221278
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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