Centerline Biomedical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Centerline Biomedical, Inc.” (first 2019, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 82 days. Since 2017 the median was 82 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 153 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 138 |
| 2024 | 2 | 82 |
| 2025 | 1 | 83 |
| 2026 | 2 | 54 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Centerline Biomedical, Inc. took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Centerline Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | DQK | 2026-06-10 | 49 |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | DQK | 2026-02-17 | 60 |
| K243842 | Intra-Operative Positioning System (IOPS®) | DQK | 2025-03-06 | 83 |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | DQK | 2024-10-11 | 81 |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | DQK | 2024-07-24 | 82 |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | DQK | 2023-06-21 | 138 |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | DQK | 2019-06-24 | 153 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-04-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Centerline Biomedical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Centerline Biomedical, Inc.” (first 2019, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Centerline Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Centerline Biomedical, Inc. is 82 days. Since 2017: 82 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Centerline Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 7).
Next steps
- See all 7 Centerline Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Centerline Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.