510(k) · Cleared
Recalled · Class II · 2025Sheathes Ultrasound Probe Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheathing Technologies, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Mar 4, 2016 as substantially equivalent to K990175 (Sheathing Technologies, Inc., 1999) after a 120-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Mar 4, 2016
- Review
- 120 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990175 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990175 Sheathes (Non-Latex), SterileSheathing Technologies, Inc. · 1999
- This deviceK153212 Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990175 | Sheathes (Non-Latex), Sterile | Sheathing Technologies, Inc. | 1999 | — |
| 0 (this device) | K153212 | Sheathes Ultrasound Probe Covers | Sheathing Technologies, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K990175 | Sheathes (Non-Latex), SterileSummary page 3…ber (if known) K153212 Device Name Sheathes Ultrasound Probe Covers Indications for Use (Describe) The intended use of the device is identical to the predicate 510(k) K990175 except for the removal of the word ‘sterile’ (as the device may be sold either sterile or non-sterile), and the change of 'Latex-… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2025 | Class II | Z-1006-2026 | Process control | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Polyurethane probe covers are indicated during diagnostic ultrasound procedures in cases where patient sensitivity to latex is speculative.
Polyurethane probe covers are contraindicated during diagnostic ultrasound procedures in cases where patients exhibit a history of hypersensitivity to the material components.
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/K153212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153212: Sheathes Ultrasound Probe Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153212
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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