# Centerline Biomedical, Inc.

- Location (FDA's records): Cleveland, OH
- FDA decisions: 8 (2019–2026): 8 510(k) clearances
- Names in FDA's records: Centerline Biomedical, Inc. (6); Centerline Biomedical (2)
- Product codes: DQK (8)
- 510(k) review time since 2016: median 82 days, against 123 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 14 (11 its own); citations of its devices by later devices: 11 (11 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- St. Jude Medical, Cardiac Rhythm Management Divisi: 1 (https://510kreport.com/company/st-jude-medical-cardiac-rhythm-management-divisi)

## Its most-cited devices
- K190106: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (2019), cited by 4
- 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) (2023), cited by 3
- K243842: Intra-Operative Positioning System (IOPS®) (2025), cited by 2
- K242133: Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (2024), cited by 1
- K241243: Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (2024), cited by 1

## Recent decisions
- K263016: Intra-Operative Positioning System (IOPS) and IOPS Visionary System (Oct 1, 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) (Jun 10, 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) (Feb 17, 2026)
- K243842: Intra-Operative Positioning System (IOPS®) (Mar 6, 2025)
- K242133: Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (Oct 11, 2024)
- K241243: Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (Jul 24, 2024)
- 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) (Jun 21, 2023)
- K190106: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (Jun 24, 2019)

Source page: https://510kreport.com/company/centerline-biomedical