510(k) · Cleared
ClearedBI-Flex Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promepla Sam · KNY Accessories, Catheter, G-U
Cleared on Jun 17, 2014 as substantially equivalent to K120160 (Promepla Sam, 2012) after a 116-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jun 17, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961904 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 3 generations backK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- 2 generations backK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- 1 generation backK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
- This deviceK140441 BI-Flex Ureteral Access SheathPromepla Sam · 2014
- Descendant · cites it directly · 0 of its ownK182144 Bi-Flex EvoPromepla Sam · 2018
Most influential descendants
Showing 1 of 1 · See all- K182144Bi-Flex EvoPromepla Sam · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −3 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| −2 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| −1 | K120160 | Rocamed Rocaus Platinum | Promepla Sam | 2012 | — |
| 0 (this device) | K140441 | BI-Flex Ureteral Access Sheath | Promepla Sam | 2014 | — |
| +1 | K182144 | Bi-Flex Evo | Promepla Sam | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K120160 | Rocamed Rocaus PlatinumSummary page 1…KNY CFR Reference: 21 CFR 876.5130 C. Predicate Device Name: Trade Name: ROCAMED RocaUS Platinum (K120160) D. Device Description: The Bi-Flex Ureteral Access Sheath is designed to create a conduit for urological procedural in… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182144 | Bi-Flex Evo | 2018 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K182144 (Promepla Sam, 2018) 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. 2014, this device’s year, is highlighted.
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 Bi-Flex Ureteral Access Sheath is intended to be a conduit for passage of endloscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140441 · printed Nov 3, 2026
Cite this page
510(k) Report. “K140441: BI-Flex Ureteral Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140441
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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