510(k) · Cleared
ClearedSheathesiso Ultrasound Transducer Cover
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 Sep 28, 2009 as substantially equivalent to K013721 (CIVCO Medical Instruments Co., Inc., 2001) and 1 other predicate after a 101-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Sep 28, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K895614 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 3 generations backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- 2 generations backK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- 1 generation backK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
- This deviceK091828 Sheathesiso Ultrasound Transducer CoverSheathing Technologies, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −3 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| −2 | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover… | CIVCO Medical Instruments Co., Inc. | 1999 | — |
| −1 | K013721 | Synthetic Polysioprene Ultrasound Transducer Cover | CIVCO Medical Instruments Co., Inc. | 2001 | 3 |
| 0 (this device) | K091828 | Sheathesiso Ultrasound Transducer Cover | Sheathing Technologies, Inc. | 2009 | — |
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? (2)
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 |
|---|---|---|---|
| * | K013721 | Synthetic Polysioprene Ultrasound Transducer CoverSummary page 2…rasonic Diagnostic Transducer Accessories 5-1 Equivalence: 510(K) K013721, Synthetic Polyisoprene Ultrasound Transducer Cover, Civco Medical Instruments… | 2001 |
| * | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip…Summary page 2…510(K) K013721, Synthetic Polyisoprene Ultrasound Transducer Cover, Civco Medical Instruments 510(K) K991236, NeoFlexTM Ultrasound Transducer Cover, Civco Medical Instruments Labeling and Usage: The following inf… | 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)
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 20 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K013721.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091828: Sheathesiso Ultrasound Transducer Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091828
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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