Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Centerline Biomedical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
153 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Ca | Centerline Biomedical, Inc. | 2026-02-17 | 60 | 0 |
| K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025-03-06 | 83 | 1 |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Trackin | Centerline Biomedical, Inc. | 2024-10-11 | 81 | 1 |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple | Centerline Biomedical, Inc. | 2024-07-24 | 82 | 1 |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simp | Centerline Biomedical, Inc. | 2023-06-21 | 138 | 1 |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, R | Centerline Biomedical, Inc. | 2019-06-24 | 153 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda