510(k) · Cleared
ClearedGeneral Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip Intraoperative 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 Jun 2, 1999 as substantially equivalent to K970515 (CIVCO Medical Instruments Co., Inc., 1997) after a 51-day review. Its family tree reaches back 2 generations to 1989. 16 later devices descend from it.
- Decided
- Jun 2, 1999
- Review
- 51 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895614 (1989). 16 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 1 generation backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- This deviceK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- Descendant · cites it directly · 14 of its ownK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
- Descendant · 2 generations on · 10 of its ownK041077 Imalux Oct Probe GuideImalux Corporation · 2004
- Descendant · 3 generations on · 9 of its ownK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- Descendant · 4 generations on · 6 of its ownK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- Descendant · 5 generations on · 5 of its ownK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K013721Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · cites it directly14descendants
- K041077Imalux Oct Probe GuideImalux Corporation · 2004 · 2 generations on10descendants
- K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011 · 3 generations on9descendants
- K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013 · 4 generations on6descendants
- K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 2015 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −1 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| 0 (this device) | 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 |
| +2 | K041077 | Imalux Oct Probe Guide | Imalux Corporation | 2004 | — |
| +3 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| +4 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| +5 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K970515 | General Purpose Latex Transducer CoversSummary page 2…t to CIVCO Medical’s currently, legally marketed Latex Ultrasound Transducer Covers: Predicate Device(s) 510(k) Reference Manufacturer Latex Ultrasound Transducer Cover K970515 CIVCO Medical E. Substantial Equivalence Summary The NeoFlex™ Ultrasound Transducer Cover is substantially equivalent in safety… | 1997 |
What descends from it? (16)
See all 163 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 10 years and passes through 1 company; a new generation was cleared every 7.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K013721 (CIVCO Medical Instruments Co., Inc., 2001) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K970515.
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 placed over diagnostic 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 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 (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO NeoFlex™ Ultrasound Transducer Covers are furnished sterile & 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/K991236 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991236: General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip Intraoperative 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/K991236
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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