510(k) · Cleared
Recalled · Class II · 2023Visera Hysterovideoscope Olympus Hyf Type V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · HIH Hysteroscope (And Accessories)
Cleared on Jan 24, 2003 as substantially equivalent to K891451 (Olympus Corp., 1989) after a 183-day review. Its family tree reaches back 1 generation to 1989. 24 later devices descend from it. It has been recalled once.
- Decided
- Jan 24, 2003
- Review
- 183 days
- Class
- Class II
- Product code
- HIH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891451 (1989). 24 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK891451 Olympus Hyf-P Flexible HysterofiberscopeOlympus Corp. · 1989 · Recalled
- This deviceK022445 Visera Hysterovideoscope Olympus Hyf Type VOlympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 22 of its ownK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- Descendant · 2 generations on · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- Descendant · 3 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- Descendant · 3 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 4 generations on · 4 of its ownK202445 Hystero-V HysteroscopeHysterovue, Inc. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009 · cites it directly22descendants
- K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · 2 generations on20descendants
- K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 3 generations on19descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 3 generations on5descendants
- K202445Hystero-V HysteroscopeHysterovue, Inc. · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891451 | Olympus Hyf-P Flexible Hysterofiberscope | Olympus Corp. | 1989 | 1 |
| 0 (this device) | K022445 | Visera Hysterovideoscope Olympus Hyf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | Gyrus Acmi, Inc. | 2009 | — |
| +2 | K123151 | Endosee Model 8000 U-Scope | Endosee Corp | 2013 | — |
| +3 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | — |
| +3 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +4 | K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K963033 | FDA’s K963033 is BF 240/P240/IT240 Bronchovideoscope & Accessories Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1996 |
| * | K891451 | Olympus Hyf-P Flexible HysterofiberscopeSummary page 1…BF-240 #Kg63033 Olympus Optical Co., Olympus HYF-P Flexible hysterofiberscope #K89 1451 n Oly… | 1989 |
What descends from it? (24)
See all 242 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 |
|---|---|---|---|---|
| Jul 20, 2023 | Class II | Z-2480-2023 | Reprocessing Controls | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes. |
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?
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus, including:
- Abnormal uterine bleeding
- Evaluation of'abnormal hysterosalpingogram
- Evaluation of abnormal ultrasound image
- Infertility and pregnancy wastage
- Pelvic pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022445: Visera Hysterovideoscope Olympus Hyf Type V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022445
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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