510(k) · Cleared
ClearedUltraDrape UGPIV Barrier and Securement (34-15)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parker Laboratories, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 15, 2024 as substantially equivalent to K221278 (Hony Medical Co., Ltd., 2023) after a 244-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Aug 15, 2024
- Review
- 244 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K844472 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK844472 Civco Scan DrapeCIVCO Medical Instruments Co., Inc. · 1985
- 2 generations backK970513 General Purpose Tranducer CoverCIVCO Medical Instruments Co., Inc. · 1997
- 1 generation backK221278 Transducer Probe CoverHony Medical Co., Ltd. · 2023
- This deviceK233965 UltraDrape UGPIV Barrier and Securement (34-15)Parker Laboratories, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844472 | Civco Scan Drape | CIVCO Medical Instruments Co., Inc. | 1985 | — |
| −2 | K970513 | General Purpose Tranducer Cover | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| −1 | K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023 | — |
| 0 (this device) | K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221278 | Transducer Probe CoverSummary page 4…nic transducer Transducer, Ultrasonic, Diagnostic 892.1570 ITX 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221278 Hony Medical Co. Transducer Probe Covers ITX N/A UltraDrape UGPIV Barrier and Securement KGX Device Description Summary 21 CFR… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K221278.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
UltraDrape UGPIV Barrier and Securement, a sterile, single-use disposable device, serves as a
sterile, viral barrier when used in conjunction with ultrasound transducers to shield patients from the
potential transfer of contaminants and biological risk agents that may be introduced during
ultrasound scanning and needle-guided procedures. It also serves as a transparent dressing to
protect and secure devices to the patient’s skin when required. UltraDrape UGPIV Barrier and
Securement is indicated for adults and pediatric patients. For use by healthcare professionals
appropriately trained in ultrasound within healthcare settings utilizing ultrasound.
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/K233965 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233965: UltraDrape UGPIV Barrier and Securement (34-15).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233965
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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