510(k) · Cleared
ClearedCVAC Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calyxo, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Apr 13, 2026 as substantially equivalent to K233472 (Calyxo, Inc., 2024) after a 21-day review. Its family tree reaches back 10 generations to 1993. 2 of the 31 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 13, 2026
- Review
- 21 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931154 (1993). 30 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 2 generations backK180367 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018
- 1 generation backK233472 CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · Recalled (Class I)
- This deviceK260965 CVAC Aspiration SystemCalyxo, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 6 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 5 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 4 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 3 generations backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 2 generations backK180367 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018
- 1 generation backK233472 CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · Recalled (Class I)
- This deviceK260965 CVAC Aspiration SystemCalyxo, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −6 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −5 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −4 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −3 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| −2 | K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2018 | — |
| −1 | K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | 2024 | Class I |
| 0 (this device) | K260965 | CVAC Aspiration System | Calyxo, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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.
2 devices in this family have a Class I recall. 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K233472 | CVAC Aspiration System + CVAC Image ProcessorSummary page 5…Gastroenterology / Urology 3. PREDICATE DEVICE The predicate device is the CVAC Aspiration System, which is part of the CVAC Set cleared under K233472. 4. DESCRIPTION OF THE DEVICE The single use CVAC Aspiration System and the reusable CVAC Image Processor are designed to wo… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 30 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K233472.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of…
Read the full statement (113 words)
The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.
The steerable ureteral catheter is used for irrigation and aspiration of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System + CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260965: CVAC Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260965
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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