MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.
MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. (Iowa): 510(k) cleared for Tomy International, Inc. Its amount of 140 is above the median of 138 (52nd percentile). Dated 19 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 140 · 52th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related IA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261782 |
| Device | MODO DUO Electric Pump (B11621, B11673) |
| Applicant | Tomy International, Inc. |
| Specialty / panel | Obstetrics/Gynecology |
| Product code | HGX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-29 |
| Decision date | 2026-10-16 |
| Review time (days) | 140 |
| Third-party review | No |
| Applicant location | Dyersville, IA, US |
| amount percentile | 52th of 414 (median 138, 1.0x median) |
| Peer records CSV (2 IA records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. and 2 Iowa peers
- Iowa FDAPulse records like this one: 2
- MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.'s amount: 52nd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Iowa peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 140-day review: this device is a strong predicate for similar products.
- Posted 19 days ago.
What is the FDAPulse record for MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. in Iowa?
MODO DUO Electric Pump (B11621, B11673) (K261782) by Tomy International, Inc. was cleared on 2026-10-16 after 140 days of review.
How does MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. compare to other Iowa FDAPulse records?
Its amount of 140 sits in the upper half (52th percentile) of 414 records; the median is 138. It is 19 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
MODO DUO Electric Pump (B11621, B11673) (K261782) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| MODO DUO Electric Pump (B11621, B11673) (K261782) | IA | 2026-10-16 |
| UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252) | DE | 2026-09-25 |
| KARL STORZ SUPRALOOP (K254303) | DE | 2026-09-24 |
| Everslide (K260117) | OK | 2026-09-23 |
Compare MODO DUO Electric Pump (B11621, B11673) (K261782) vs UNIDRIVE Select System (K261102) →
Compare MODO DUO Electric Pump (B11621, B11673) (K261782) vs Fertilis microICSI Device (K262090) →
Related records
- UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG
- KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG
- Everslide (K260117): 510(k) cleared for Special Situations, LLC
- Wearable Breast Pump (Model S36) (K254203): 510(k) cleared for Shenzhen TPH Technology Co., Ltd.
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