510(k) · Cleared
ClearedRocamed Rocaus Platinum
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 May 14, 2012 as substantially equivalent to K051593 (Acmi Corporation, 2005) and 1 other predicate after a 116-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- May 14, 2012
- Review
- 116 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961904 (1996). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 2 generations backK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- 1 generation backK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- This deviceK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
- Descendant · cites it directly · 1 of its ownK140441 BI-Flex Ureteral Access SheathPromepla Sam · 2014
- Descendant · 2 generations on · 0 of its ownK182144 Bi-Flex EvoPromepla Sam · 2018
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 |
|---|---|---|---|---|---|
| −3 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −2 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| −1 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| 0 (this device) | K120160 | Rocamed Rocaus Platinum | Promepla Sam | 2012 | — |
| +1 | K140441 | BI-Flex Ureteral Access Sheath | Promepla Sam | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K051593 | Uropass Ureteral Access Sheath, Model 61224Summary page 1…KNY CFR Reference: 21 CFR 876.5130 C. Predicate Device Name: Trade Names: AMCI UroPass Ureteral Access Sheath (K051593) Boston Scientific Navigator Access Sheath Set 11(K030956) D. Device Description: Th… | 2005 |
| * | K030956 | Navigator Ureteral Access Sheath SetSummary page 1…Trade Names: AMCI UroPass Ureteral Access Sheath (K051593) Boston Scientific Navigator Access Sheath Set 11(K030956) D. Device Description: The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instrume… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140441 | BI-Flex Ureteral Access Sheath | 2014 | 1 |
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 16 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K140441 (Promepla Sam, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K051593.
How does its category compare?
All KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ROCAMED RocaUS Platinum is intended to be a condluit 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/K120160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120160: Rocamed Rocaus Platinum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120160
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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