# Medtronic, Inc.

- Location (FDA's records): Mounds View, MN
- FDA decisions: 290 (1981–2026): 248 510(k) clearances and 42 original PMA approvals
- Names in FDA's records: Medtronic, Inc. (255); Medtronic (35)
- Product codes: DWF (31), MXD (17), DTZ (16), DQY (15), OCL (11), DTE (8), KFM (7), DQX (6), DSI (6), DQK (6), GEI (6), DRF (5)
- 510(k) review time since 2016: median 80 days, against 90 for FDA's reviews in the same codes and years (53 of 92 faster)
- Predicates its devices cite: 466 (147 its own); citations of its devices by later devices: 262 (147 its own)
- Recalls linked to its devices: 485 (260 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Vascular: 77 (https://510kreport.com/company/medtronic-vascular)
- Medtronic Sofamor Danek USA, Inc.: 29 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Perfusion Systems: 26 (https://510kreport.com/company/medtronic-perfusion-systems)
- Dlp, Inc.: 23 (https://510kreport.com/company/dlp)
- Medtronic Sofamor Danek: 9 (https://510kreport.com/company/medtronic-sofamor-danek)
- Avecor Cardiovascular, Inc.: 8 (https://510kreport.com/company/avecor-cardiovascular)
- Medtronic Bio-Medicus, Inc.: 8 (https://510kreport.com/company/medtronic-bio-medicus)
- Bio Medicus, Inc.: 7 (https://510kreport.com/company/bio-medicus)

## Firms that cite its devices most
- Medtronic Sofamor Danek USA, Inc.: 21 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Vascular: 6 (https://510kreport.com/company/medtronic-vascular)
- Medtronic, Ireland: 5 (https://510kreport.com/company/medtronic-ireland)
- Tecres S.P.A.: 5 (https://510kreport.com/company/tecres)
- Medicrea International SA: 4 (https://510kreport.com/company/medicrea-international)
- St Jude Medical: 4 (https://510kreport.com/company/st-jude-medical)
- Visionsense, Ltd.: 4 (https://510kreport.com/company/visionsense)
- Medtronic Perfusion Systems: 3 (https://510kreport.com/company/medtronic-perfusion-systems)

## Its most-cited devices
- K223494: CD Horizon Spinal System (2023), cited by 9
- K221244: CD Horizon™ Spinal System (2022), cited by 7
- K210637: CD Horizon™ Spinal System (2021), cited by 7
- K202771: CD Horizon Spinal System (2020), cited by 6
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), cited by 6
- K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device (2008), cited by 5

## Recent decisions
- K261792: DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (Oct 23, 2026)
- K262913: Protégé™ EverFlex™ Self-expanding Peripheral Stent System (Sep 17, 2026)
- K262735: LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) (Aug 28, 2026)
- K262005: Affera Integrated Mapping System (Aug 21, 2026)
- K261335: VitalFlow Set with Balance™ Biosurface (Jul 31, 2026)
- K261866: Concerto Versa™ Detachable Coil (Jun 24, 2026)
- K253530: Trexon™ Monofilament Synthetic Absorbable Suture (May 28, 2026)
- K260195: Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (Apr 23, 2026)

Source page: https://510kreport.com/company/medtronic