510(k) · Cleared
ClearedUniversal Operating Hysteriscope Set by Solima-Zupi, Consisting of Optic, Inner and Outer Sheaths, Forceps, Model 8753
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 Dec 23, 2003 as substantially equivalent to K880314 (Richard Wolf Medical Instruments Corp., 1988) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Dec 23, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880314 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880314 Hysteroscope Autonom 4992Richard Wolf Medical Instruments Corp. · 1988
- This deviceK033113 Universal Operating Hysteriscope Set by Solima-Zupi, Consisting of…Richard Wolf Medical Instruments Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880314 | Hysteroscope Autonom 4992 | Richard Wolf Medical Instruments Corp. | 1988 | — |
| 0 (this device) | K033113 | Universal Operating Hysteriscope Set by Solima-Zupi, Consisting of Optic… | Richard Wolf Medical Instruments Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K880314 | Hysteroscope Autonom 4992Summary page 1…Manufacturer I pre- I Hysteroscopes and Accessories I Richard Wolf amendment 4998, 8998 2 K880314/B 2 Hysteroscope Autonom 4995 2 Richard Wolf 3 K000673 3 Hysteroscope Operating Sheat… | 1988 |
| * | K000673 | Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241Summary page 1…s I Richard Wolf amendment 4998, 8998 2 K880314/B 2 Hysteroscope Autonom 4995 2 Richard Wolf 3 K000673 3 Hysteroscope Operating Sheaths and 3 Richard Wolf Inserts… | 2000 |
| * | — | Hysteroscopes and Accessories 4998, 8998 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K880314.
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 Universal Operating Hysteroscope Set is used for dilating the cervical channel, the cavum uteris (using fluid or CO 2 gas), and for visualization of the tubal ostia. The scope is applied via the natural passage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033113: Universal Operating Hysteriscope Set by Solima-Zupi, Consisting of Optic, Inner and Outer Sheaths, Forceps, Model 8753.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033113
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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