510(k) · Cleared
Recalled · Class II · 2026Adult Resectoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Video · HIH Hysteroscope (And Accessories)
Cleared on Feb 6, 1990 after a 379-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 6, 1990
- Review
- 379 days
- Class
- Class II
- Product code
- HIH
- Recalls
- 7
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK890328 Adult ResectoscopeCircon Video · 1990
- Descendant · cites it directly · 3 of its ownK022480 Acmi Disposable Bipolar Cord, Model DBCAcmi Corporation · 2002
- Descendant · 2 generations on · 2 of its ownK062720 S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK250522 Multi4 SystemMulti4 Medical AB · 2025
- Descendant · cites it directly · 0 of its ownK031758 Acmi M4 TelescopesAcmi Corporation · 2003
Most influential descendants
Showing 5 of 5 · See all- K022480Acmi Disposable Bipolar Cord, Model DBCAcmi Corporation · 2002 · cites it directly3descendants
- K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · 2 generations on2descendants
- K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · 3 generations on1descendant
- K250522Multi4 SystemMulti4 Medical AB · 2025 · 4 generations on0descendants
- K031758Acmi M4 TelescopesAcmi Corporation · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890328 | Adult Resectoscope | Circon Video | 1990 | — |
| +1 | K022480 | Acmi Disposable Bipolar Cord, Model DBC | Acmi Corporation | 2002 | — |
| +2 | K062720 | S-Line Bipolar Resectoscopes and Bipolar Electrodes | Richard Wolf Medical Instruments Corp. | 2007 | 2 |
| +3 | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +4 | K250522 | Multi4 System | Multi4 Medical AB | 2025 | — |
| +1 | K031758 | Acmi M4 Telescopes | Acmi Corporation | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2026 | Class II | Z-3300-2026 | Process control | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. |
| Aug 24, 2026 | Class II | Z-3299-2026 | Process control | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. |
| May 5, 2026 | Class II | Z-2720-2026 | Under Investigation by firm | Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. |
| Jun 18, 2025 | Class II | Z-2139-2025 | Packaging change control | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). |
| Jun 18, 2025 | Class II | Z-2140-2025 | Packaging change control | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). |
| Oct 2, 2023 | Class II | Z-0568-2024 | Labeling Change Control | Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. |
| Apr 17, 2018 | Class II | Z-1952-2018 | Device Design | There is a potential for the cord to spark and cause a fire. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022480 (Acmi Corporation, 2002) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K890328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K890328: Adult Resectoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890328
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026