Data / Medical devices / United States / Centerline Biomedical
Centerline Biomedical: FDA-registered device maker in Cleveland, OH, United States, 8 510(k) clearances
Centerline Biomedical is registered with the FDA (registration 3012154226) in Cleveland, OH, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 1, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012154226
- Address
- 4535 Renaissance Pkwy, Cleveland, OH, United States, 44128
- Owner or operator
- Centerline Biomedical (10061285)
- Roles
- Manufacturer
- First device listed
- October 4, 2019
- Registered through
- 2027
- Brand names listed
- IOPS, IOPS Intra-Operative Positioning System, IOPS Viewpoint, IOPS Visionary, IOPS Visionary System, Intra-Operative Positioning System (IOPS), Intra-Operative Positioning System (IOPS®)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 2026 | K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | DQK | Substantially Equivalent | Centerline Biomedical | accessdata.fda.gov |
| June 10, 2026 | 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 | Substantially Equivalent | Centerline Biomedical | accessdata.fda.gov |
| February 17, 2026 | 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 | Substantially Equivalent | Centerline Biomedical, Inc. | accessdata.fda.gov |
| March 6, 2025 | K243842 | Intra-Operative Positioning System (IOPS®) | DQK | Substantially Equivalent | Centerline Biomedical, Inc. | accessdata.fda.gov |
| October 11, 2024 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | DQK | Substantially Equivalent | Centerline Biomedical, Inc. | accessdata.fda.gov |
| July 24, 2024 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | DQK | Substantially Equivalent | Centerline Biomedical, Inc. | accessdata.fda.gov |
| June 21, 2023 | 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 | Substantially Equivalent | Centerline Biomedical, Inc. | accessdata.fda.gov |
| June 24, 2019 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | DQK | Substantially Equivalent | Centerline Biomedical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 11, 2025 | 96697 | Class I | Ongoing | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Catheter, Percutaneous
- All makers of Wire, Guide, Catheter
Updated October 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.