Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.
Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.: 510(k) cleared for Fertilis Pty, Ltd. Its amount of 109 is below the median of 138 (39th percentile). Dated 26 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: 109 · 39th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related AU FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262090 |
| Device | Fertilis microICSI Device |
| Applicant | Fertilis Pty, Ltd. |
| Specialty / panel | Obstetrics/Gynecology |
| Product code | MQK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-22 |
| Decision date | 2026-10-09 |
| Review time (days) | 109 |
| Third-party review | No |
| Applicant location | Adelaide, AU |
| amount percentile | 39th of 414 (median 138, 0.8x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-09
- 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: Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd. and 2 AU peers
- AU FDAPulse records like this one: 2
- Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.'s amount: 39th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every AU peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 109-day review: this device is a strong predicate for similar products.
- Posted 26 days ago.
What is the FDAPulse record for Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.?
Fertilis microICSI Device (K262090) by Fertilis Pty, Ltd. was cleared on 2026-10-09 after 109 days of review.
How does Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd. compare to other FDAPulse records?
Its amount of 109 is below the median (39th percentile); smaller records often move faster and face less competition. It is 26 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.
Fertilis microICSI Device (K262090) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Fertilis microICSI Device (K262090) | AU | 2026-10-09 |
| 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 Fertilis microICSI Device (K262090) vs MODO DUO Electric Pump (B11621, B11673) (K261782) →
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- KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Obstetrics & Gynecology devices
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