# Covidien

- Location (FDA's records): Boulder, CO
- FDA decisions: 227 (1991–2026): 224 510(k) clearances, 1 De Novo grant and 2 original PMA approvals
- Names in FDA's records: Covidien (131); Covidien, LLC (92); Covidien LP (4)
- Product codes: GEI (41), GDW (27), GCJ (13), DQA (10), JOW (8), JOH (7), BTR (6), NEY (5), GAG (5), KNT (4), MWI (4), CBK (4)
- 510(k) review time since 2016: median 107 days, against 106 for FDA's reviews in the same codes and years (59 of 104 faster)
- Predicates its devices cite: 368 (134 its own); citations of its devices by later devices: 274 (134 its own)
- Recalls linked to its devices: 213 (36 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- United States Surgical, A Division of Tyco Healthc: 22 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Covidien, Formerly US Surgical A Divison of Tyco H: 19 (https://510kreport.com/company/covidien-formerly-us-surgical-a-divison-of-tyco-h)
- Valleylab, Inc.: 12 (https://510kreport.com/company/valleylab)
- Covidien, Formerly Valleylab, A Division of Tyco H: 10 (https://510kreport.com/company/covidien-formerly-valleylab-a-division-of-tyco-h)
- Kendall: 10 (https://510kreport.com/company/kendall)
- Mallinckrodt Medical: 8 (https://510kreport.com/company/mallinckrodt-medical)
- Tyco Healthcare/Kendall: 7 (https://510kreport.com/company/tyco-healthcare-kendall)
- Nellcor Puritan Bennett, Inc.: 6 (https://510kreport.com/company/nellcor-puritan-bennett)

## Firms that cite its devices most
- Medtronic, Inc.: 5 (https://510kreport.com/company/medtronic)
- Conmed Corporation: 4 (https://510kreport.com/company/conmed)
- Stryker Sustainability Solutions: 4 (https://510kreport.com/company/stryker-sustainability-solutions)
- Taiwan Surgical Corporation: 4 (https://510kreport.com/company/taiwan-surgical)
- Surgical Instrument Service and Savings, Inc.: 3 (https://510kreport.com/company/surgical-instrument-service-and-savings)
- Covidien, Formerly US Surgical A Divison of Tyco H: 3 (https://510kreport.com/company/covidien-formerly-us-surgical-a-divison-of-tyco-h)
- Capnostics, LLC: 3 (https://510kreport.com/company/capnostics)
- Bolder Surgical, LLC: 3 (https://510kreport.com/company/bolder-surgical)

## Its most-cited devices
- K141153: Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw One Step Stealer/Dividers, Curved (2014), cited by 11
- K133821: Emprint Ablation System (2014), cited by 8
- K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (2017), cited by 7
- K163105: Emprint Ablation System (2016), cited by 6
- K111887: Closurefast Radiofrequency Catheter (2011), cited by 6
- K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices (2009), cited by 6

## Recent decisions
- K261070: LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (Sep 15, 2026)
- K260907: BIS™ Advance pEEG Module (Aug 13, 2026)
- K253527: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (Jul 1, 2026)
- K253984: Instrument Exit Point on Touch Surgery™ Aide (Jun 4, 2026)
- K253030: Capnostream™35 Portable Respiratory Monitor (PM35MN) (May 1, 2026)
- K251025: Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (Dec 29, 2025)
- K251313: Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT (Dec 29, 2025)
- K250725: Hugo™ RAS System (Dec 3, 2025)

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