510(k) · Cleared
ClearedUNIDRIVE SIII System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz-Endoscopy-America, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Apr 27, 2023 as substantially equivalent to K132015 (Smith & Nephew, Inc., 2013) and 1 other predicate after a 155-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 27, 2023
- Review
- 155 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953695 (1995). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 3 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 1 generation backK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
- This deviceK223520 UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK254252 UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating…Karl Storz SE & CO. KG · 2026
- Descendant · cites it directly · 0 of its ownK261102 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −3 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| −1 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
| 0 (this device) | K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | 2023 | — |
| +1 | K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath… | Karl Storz SE & CO. KG | 2026 | — |
| +1 | K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132015 | Truclear Morcellation System and Truclear MorcellatorsSummary page 4…HIH Classification Obstetrics/Gynecology Panel: Predicate Primary Predicate: TRUCLEAR Morcellator System and TRUCLEAR Device(s): Morcellators (K132015) The primary predicate has been subject to a design related recall Secondary Predicate: KA… | 2013 |
| * | K935716 | Karl Storz Fixed Magnification Telescope/KS Variable Magnification TelescopeSummary page 4…32015) The primary predicate has been subject to a design related recall Secondary Predicate: KARL STORZ Magnifying Hysteroscopes (K935716) The secondary predicate has not been subject to any recall Device The UNIDRIVE® SIII system is a… | 1995 |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K254252 (Karl Storz SE & CO. KG, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K132015.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 UNIDRIVE SIII System is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue.
The HOPKINS Telescope when used with the obturator is intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223520 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223520: UNIDRIVE SIII System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223520
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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