510(k) · Cleared
ClearedBi-Flex Evo
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 Sep 7, 2018 as substantially equivalent to K140441 (Promepla Sam, 2014) after a 30-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Sep 7, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961904 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 4 generations backK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- 3 generations backK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- 2 generations backK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
- 1 generation backK140441 BI-Flex Ureteral Access SheathPromepla Sam · 2014
- This deviceK182144 Bi-Flex EvoPromepla Sam · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −4 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| −3 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| −2 | K120160 | Rocamed Rocaus Platinum | Promepla Sam | 2012 | — |
| −1 | K140441 | BI-Flex Ureteral Access Sheath | Promepla Sam | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K140441 | BI-Flex Ureteral Access SheathSummary page 4…N° Product name Manufacturer 510(k) number 1 Bi-Flex Ureteral Access Sheath PROMEPLA SAM K140441 Section 5 CONFIDENTIAL Page 1 of 2… | 2014 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 9 ancestors has 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. 2018, 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 BiFlex Evo is intended to be a conduit for passage of endoscopes 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/K182144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182144: Bi-Flex Evo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182144
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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