510(k) · Cleared
ClearedHysteroscope Autonom 4992
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HIH Hysteroscope (And Accessories)
Cleared on Aug 25, 1988 after a 212-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Aug 25, 1988
- Review
- 212 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 5 citing it directly.
- This deviceK880314 Hysteroscope Autonom 4992Richard Wolf Medical Instruments Corp. · 1988
- Descendant · cites it directly · 21 of its ownK962256 Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996
- Descendant · 2 generations on · 20 of its ownK031974 Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH · 2003
- Descendant · 3 generations on · 19 of its ownK060899 Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
- Descendant · 4 generations on · 18 of its ownK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · Recalled
- Descendant · 5 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K962256Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996 · cites it directly21descendants
- K031974Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00…Asap Endoscopic Products GmbH · 2003 · 2 generations on20descendants
- K060899Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007 · 3 generations on19descendants
- K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · 4 generations on18descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880314 | Hysteroscope Autonom 4992 | Richard Wolf Medical Instruments Corp. | 1988 | — |
| +1 | K962256 | Galileo Hysteroscopes and Laparoscopes | Galileo Electro-Optics Corp. | 1996 | — |
| +2 | K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00… | Asap Endoscopic Products GmbH | 2003 | — |
| +3 | K060899 | Flexilux II Cystoscope and Hysteroscope | Schoelly Imaging, Inc. | 2007 | — |
| +4 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015 | 1 |
| +5 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (26)
See all 265 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K962256 (Galileo Electro-Optics Corp., 1996) has gone furthest, with 21 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/K880314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K880314: Hysteroscope Autonom 4992.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880314
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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