510(k) · Cleared
ClearedCarevent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chief Medical, LLC · KNY Accessories, Catheter, G-U
Cleared on Oct 16, 2006 as substantially equivalent to K041983 (Opticon Medical, 2004) and 1 other predicate after a 75-day review. Its family tree reaches back 5 generations to 1976.
- Decided
- Oct 16, 2006
- Review
- 75 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K760093 (1976). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK760093 Catheter, Silicone Foley (Bardex)C.R. Bard, Inc. · 1976 · Recalled
- 4 generations backK961697 Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996
- 3 generations backK023090 Option-VF Urinary Catheter, FV14218Opticon Medical, Inc. · 2003 · Recalled
- 2 generations backK033830 Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V…Opticon Medical, Inc. · 2004
- 1 generation backK041983 Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical · 2004 · Recalled
- This deviceK062240 CareventChief Medical, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K760093 | Catheter, Silicone Foley (Bardex) | C.R. Bard, Inc. | 1976 | 1 |
| −4 | K961697 | Opticon Female Urinary Incontinence Catheter for Continuous Drainage | Medical Device Intl., Inc. | 1996 | — |
| −3 | K023090 | Option-VF Urinary Catheter, FV14218 | Opticon Medical, Inc. | 2003 | 1 |
| −2 | K033830 | Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous… | Opticon Medical, Inc. | 2004 | — |
| −1 | K041983 | Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016 | Opticon Medical | 2004 | 1 |
| 0 (this device) | K062240 | Carevent | Chief Medical, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 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 KNY? 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 KNY device
- #1 K260919 Transurethral Catheter Safety Valve (TUCSV)…score 11.8 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K041983 | Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Summary page 1…President Intended Use The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage. Predicate Devices K041983 Option-vm Urinary Catheter Opticon Medical, Inc. K051059 AMSURE 100% Silicone Foley Cat… | 2004 |
| * | K051059 | Amsure 100% Silicone Foley CatheterSummary page 1…heter for the management of urinary drainage. Predicate Devices K041983 Option-vm Urinary Catheter Opticon Medical, Inc. K051059 AMSURE 100% Silicone Foley Catheter Amsino International, Inc. Device Description The CareVe… | 2005 |
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 30 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNY
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KNY
103in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNY
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNY
3in 2025
MAUDE reports naming product code KNY, 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 | 0 | — | 0 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 1 | 6 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 3 | 103 | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 21 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 36 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 1 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062240: Carevent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062240
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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