510(k) · Cleared
ClearedMemcath Urology Introducer Sheath, Model 201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memcath Technologies, LLC · KNY Accessories, Catheter, G-U
Cleared on Jun 5, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jun 5, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK000767 Memcath Urology Introducer Sheath, Model 201Memcath Technologies, LLC · 2000
- Descendant · cites it directly · 0 of its ownK061663 Endomedical Technologies Quik-Cover Flexible Endoscope Barrier…Rtc Inc.-Memcath Technologies, LLC · 2006
- Descendant · cites it directly · 0 of its ownK061324 Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000767 | Memcath Urology Introducer Sheath, Model 201 | Memcath Technologies, LLC | 2000 | — |
| +1 | K061663 | Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for… | Rtc Inc.-Memcath Technologies, LLC | 2006 | — |
| +1 | K061324 | Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7 | Rtc Inc.-Memcath Technologies, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 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, K061663 (Rtc Inc.-Memcath Technologies, LLC, 2006) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K000767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000767: Memcath Urology Introducer Sheath, Model 201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000767
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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