SpaceOAR Flex System (K262151): 510(k) cleared for Boston Scientific Corporation
SpaceOAR Flex System (K262151): 510(k) cleared for Boston Scientific Corporation (Massachusetts): 510(k) cleared for Boston Scientific Corporation. Its amount of 78 is below the median of 138 (22nd percentile). Dated 55 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, 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: 78 · 22th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262151 |
| Device | SpaceOAR Flex System |
| Applicant | Boston Scientific Corporation |
| Specialty / panel | Radiology |
| Product code | OVB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-25 |
| Decision date | 2026-09-11 |
| Review time (days) | 78 |
| Third-party review | No |
| Applicant location | Marlborough, MA, US |
| amount percentile | 22th of 414 (median 138, 0.6x 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: 2026-09-11
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: SpaceOAR Flex System (K262151): 510(k) cleared for Boston Scientific Corporation and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- SpaceOAR Flex System (K262151): 510(k) cleared for Boston Scientific Corporation's amount: 22nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 78-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for SpaceOAR Flex System (K262151): 510(k) cleared for Boston Scientific Corporation in Massachusetts?
SpaceOAR Flex System (K262151) by Boston Scientific Corporation was cleared on 2026-09-11 after 78 days of review.
How does SpaceOAR Flex System (K262151): 510(k) cleared for Boston Scientific Corporation compare to other Massachusetts FDAPulse records?
Its amount of 78 is below the median (22th percentile); smaller records often move faster and face less competition. It is 55 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
SpaceOAR Flex System (K262151) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| SpaceOAR Flex System (K262151) | MA | 2026-09-11 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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