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MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. vs Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.: FDAPulse comparison
MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.'s review days of 140 is 1.3x Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.'s 109 (52nd percentile). MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. is dated 2026-10-16; Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd. 2026-10-09.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. compare to Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.?
| Field | MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. | Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K261782 | K262090 |
| Device | MODO DUO Electric Pump (B11621, B11673) | Fertilis microICSI Device |
| Applicant | Tomy International, Inc. | Fertilis Pty, Ltd. |
| Specialty / panel | Obstetrics/Gynecology | Obstetrics/Gynecology |
| Product code | HGX | MQK |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-05-29 | 2026-06-22 |
| Decision date | 2026-10-16 | 2026-10-09 |
| Review time (days) | 140 | 109 |
| Third-party review | No | No |
| Applicant location | Dyersville, IA, US | Adelaide, AU |
| amount percentile | 52nd | 39th |
| Predicate Speed & CAPA Advisory Opportunity Score | 36/100 | 36/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. · Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.
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