Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical
Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical (Ohio): 510(k) cleared for Centerline Biomedical. Its amount of 34 is below the median of 138 (11th percentile). Dated 34 days ago, it serves as a historical benchmark. Score 41/100. 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: 34 · 11th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related OH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263016 |
| Device | Intra-Operative Positioning System (IOPS) and IOPS Visionary System |
| Applicant | Centerline Biomedical |
| Specialty / panel | Cardiovascular |
| Product code | DQK |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-08-28 |
| Decision date | 2026-10-01 |
| Review time (days) | 34 |
| Third-party review | No |
| Applicant location | Warrensville Heights, OH, US |
| amount percentile | 11th of 414 (median 138, 0.2x median) |
| Peer records CSV (25 OH records) | 🔒 Click to unlock → |
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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: 2026-10-01
- Data refreshed: 2026-11-04
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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: Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical and 25 Ohio peers
- Ohio FDAPulse records like this one: 25
- Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical's amount: 11th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Ohio peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 34-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 34 days ago.
What is the FDAPulse record for Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical in Ohio?
Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016) by Centerline Biomedical was cleared on 2026-10-01 after 34 days of review.
How does Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical compare to other Ohio FDAPulse records?
Its amount of 34 is below the median (11th percentile); smaller records often move faster and face less competition. It is 34 days old, still within a typical 45-day follow-up window.
Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016) | OH | 2026-10-01 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
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