510(k) · Cleared
ClearedCivco Latex Ultrasound Sheaths
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CIVCO Medical Instruments Co., Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 14, 1989 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Dec 14, 1989
- Review
- 86 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 4 citing it directly.
- This deviceK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- Descendant · cites it directly · 21 of its ownK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- Descendant · 2 generations on · 16 of its ownK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- Descendant · 3 generations on · 14 of its ownK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
- Descendant · 4 generations on · 10 of its ownK041077 Imalux Oct Probe GuideImalux Corporation · 2004
- Descendant · 5 generations on · 9 of its ownK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K970515General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997 · cites it directly21descendants
- K991236General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip…CIVCO Medical Instruments Co., Inc. · 1999 · 2 generations on16descendants
- K013721Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · 3 generations on14descendants
- K041077Imalux Oct Probe GuideImalux Corporation · 2004 · 4 generations on10descendants
- K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| +1 | 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 | — |
| +3 | K013721 | Synthetic Polysioprene Ultrasound Transducer Cover | CIVCO Medical Instruments Co., Inc. | 2001 | 3 |
| +4 | K041077 | Imalux Oct Probe Guide | Imalux Corporation | 2004 | — |
| +5 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 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 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 254 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?
- Of its descendants, K970515 (CIVCO Medical Instruments Co., Inc., 1997) has gone furthest, with 21 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K895614 · printed Nov 5, 2026
Cite this page
510(k) Report. “K895614: Civco Latex Ultrasound Sheaths.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895614
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026