510(k) · Cleared
ClearedAcmi Vista CTR Bipolar Loop Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · FAS Electrode, Electrosurgical, Active, Urological
Cleared on May 21, 2003 as substantially equivalent to K973820 (Circon Corp., 1998) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- May 21, 2003
- Review
- 51 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951972 (1995). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK951972 Cabot Medical Ultra Flow Cystourethroscope System with Operating &…Cabot Medical Corp. · 1995
- 1 generation backK021166 Acmi Bipolar Rectoscope, Model Eiwe-BRAcmi-Circon Corporation · 2002
- This deviceK031001 Acmi Vista CTR Bipolar Loop ElectrodeAcmi Corporation · 2003
- Descendant · cites it directly · 2 of its ownK062720 S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK250522 Multi4 SystemMulti4 Medical AB · 2025
Most influential descendants
Showing 3 of 3 · See all- K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · cites it directly2descendants
- K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · 2 generations on1descendant
- K250522Multi4 SystemMulti4 Medical AB · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951972 | Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic… | Cabot Medical Corp. | 1995 | — |
| −1 | K021166 | Acmi Bipolar Rectoscope, Model Eiwe-BR | Acmi-Circon Corporation | 2002 | — |
| 0 (this device) | K031001 | Acmi Vista CTR Bipolar Loop Electrode | Acmi Corporation | 2003 | — |
| +1 | K062720 | S-Line Bipolar Resectoscopes and Bipolar Electrodes | Richard Wolf Medical Instruments Corp. | 2007 | 2 |
| +2 | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +3 | K250522 | Multi4 System | Multi4 Medical AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 FAS? 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 FAS device
- #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K973820 | Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection ElectrodeSummary page 1…lation device and Accessories Predicate Devices ACMI USA Elite System Right Angle Cutting Loop Electrode - K97 3820 ACMI Bipolar Resectoscope & Loop Electrode KO2 1 166 Intended Uses Intended for use in patient… | 1998 |
| * | K021166 | Acmi Bipolar Rectoscope, Model Eiwe-BR | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062720 | S-Line Bipolar Resectoscopes and Bipolar Electrodes | 2007 | 2 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K062720 (Richard Wolf Medical Instruments Corp., 2007) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K973820.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, 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 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, Removal of Ureteral Calculus, and Treatment of Vesical Neck Constriction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031001: Acmi Vista CTR Bipolar Loop Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031001
Report an extraction error
Are you the manufacturer?
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