510(k) · Cleared
ClearedAcmi Disposable Bipolar Cord, Model DBC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · HIH Hysteroscope (And Accessories)
Cleared on Aug 22, 2002 as substantially equivalent to K890328 (Circon Video, 1990) after a 27-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Aug 22, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890328 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890328 Adult ResectoscopeCircon Video · 1990 · Recalled
- This deviceK022480 Acmi Disposable Bipolar Cord, Model DBCAcmi Corporation · 2002
- 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 |
|---|---|---|---|---|---|
| −1 | K890328 | Adult Resectoscope | Circon Video | 1990 | 7 |
| 0 (this device) | K022480 | Acmi Disposable Bipolar Cord, Model DBC | Acmi Corporation | 2002 | — |
| +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 | — |
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 HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 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 |
|---|---|---|---|
| * | K890328 | Adult ResectoscopeSummary page 1…able Bipolar Cord Generic/Common Name: Endoscope and accessories Predicate Devices ACMI Disposable Active Cord Preamendment & IC890328 Intended Uses The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element (WE) to… | 1990 |
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?
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element to an Electrosurgery unit (ESU). It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. It is intended to be sold as a sterile, single use disposable device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022480: Acmi Disposable Bipolar Cord, Model DBC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022480
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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