510(k) · Cleared
Recalled · Class II · 2015Synthetic Polysioprene Ultrasound Transducer Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CIVCO Medical Instruments Co., Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Dec 28, 2001 as substantially equivalent to K991236 (CIVCO Medical Instruments Co., Inc., 1999) after a 49-day review. Its family tree reaches back 3 generations to 1989. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 28, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895614 (1989). 14 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 2 generations backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- 1 generation backK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- This deviceK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001
- Descendant · cites it directly · 10 of its ownK041077 Imalux Oct Probe GuideImalux Corporation · 2004
- Descendant · 2 generations on · 9 of its ownK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- Descendant · 3 generations on · 6 of its ownK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- Descendant · 4 generations on · 5 of its ownK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 2 of its ownK153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon…Ninepoint Medical, Inc. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K041077Imalux Oct Probe GuideImalux Corporation · 2004 · cites it directly10descendants
- K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011 · 2 generations on9descendants
- K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013 · 3 generations on6descendants
- K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 2015 · 4 generations on5descendants
- K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc. · 2016 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −2 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| −1 | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover… | CIVCO Medical Instruments Co., Inc. | 1999 | — |
| 0 (this device) | K013721 | Synthetic Polysioprene Ultrasound Transducer Cover | CIVCO Medical Instruments Co., Inc. | 2001 | — |
| +1 | K041077 | Imalux Oct Probe Guide | Imalux Corporation | 2004 | — |
| +2 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| +3 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| +4 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | 1 |
| +5 | K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE… | Ninepoint Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip…Summary page 2…ent to CIVCO’s current, legally marketed NeoFlex™ Ultrasound Transducer Covers: Predicate Device(s) 510(k) Reference Manufacturer NeoFlex™ Ultrasound Transducer Cover ' K991236 CIVCO E. Substantial Equivalence Summary The Synthetic Polyisoprene Ultrasound Transducer Cover is substantially equivalent in… | 1999 |
What descends from it? (14)
See all 143 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2015 | Class II | Z-1400-2015 | Process design | Leaks were detected in the recalled lot which may compromise the sterility of the product. |
| Jan 21, 2011 | Not classified | Z-1607-2011 | Labeling design | Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information. |
| Jul 20, 2010 | Not classified | Z-2242-2010 | Nonconforming Material/Component | Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041077 (Imalux Corporation, 2004) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K991236.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Protective cover or sheath is placed over an ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Synthetic Polyisoprene Ultrasound Transducer Covers are furnished sterile and non-sterile, single use patient / procedure, disposable.
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/K013721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013721: Synthetic Polysioprene Ultrasound Transducer Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013721
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026