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# UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG vs MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.: FDAPulse comparison

**UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG's review days of 168 is 1.2x MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.'s 140 (61st percentile). UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG is dated 2026-09-18; MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. 2026-10-16.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA (510(k) clearances and device enforcement reports) Copy citation

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## How does UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG compare to MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.?

| Field | UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG | MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K261102 | K261782 |
| Device | UNIDRIVE Select System | MODO DUO Electric Pump (B11621, B11673) |
| Applicant | Karl Storz SE & CO. KG | Tomy International, Inc. |
| Specialty / panel | Obstetrics/Gynecology | Obstetrics/Gynecology |
| Product code | HIH | HGX |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-04-03 | 2026-05-29 |
| Decision date | 2026-09-18 | 2026-10-16 |
| Review time (days) | 168 | 140 |
| Third-party review | No | No |
| Applicant location | Tuttlingen, DE | Dyersville, IA, US |
| amount percentile | 61st | 52nd |
| Predicate Speed & CAPA Advisory Opportunity Score | 42/100 | 36/100 |
| Peer rank and all 500 records (CSV) | Every comparable record ranked, with amounts, dates and scores 🔒 Click to unlock → |
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Official records: [UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261102) · [MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261782)

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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