# Paragon Medical

- Location (FDA's records): Pierceton, IN
- FDA decisions: 5 (2003–2019): 5 510(k) clearances
- Names in FDA's records: Paragon Medical (3); Paragon Medical, Inc. (2)
- Product codes: KCT (5)
- 510(k) review time since 2016: median 127 days, against 187 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Oticon Medical AB: 1 (https://510kreport.com/company/oticon-medical)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Symmetry Medical: 1 (https://510kreport.com/company/symmetry-medical)
- Riley Medical, Inc.: 1 (https://510kreport.com/company/riley-medical)

## Firms that cite its devices most
- Conmed Corporation: 1 (https://510kreport.com/company/conmed)
- Rp Medical, Inc.: 1 (https://510kreport.com/company/rp-medical)
- Microaire Surgical Instruments, LLC: 1 (https://510kreport.com/company/microaire-surgical-instruments)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)
- T.A.G. Medical Products Corporation, Ltd.: 1 (https://510kreport.com/company/tag-medical-products)

## Its most-cited devices
- K032119: Paragon Medical Surgical Instrument Delivery System Various (2003), cited by 4
- K173615: Stryker Universal Select Sterilization Tray System (2018), cited by 2
- K152951: Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray (2015), cited by 1

## Recent decisions
- K190667: Sonopet iQ Sterilization Tray (Jun 13, 2019)
- K183701: Stryker ChestShield Sterilization Tray System (May 7, 2019)
- K173615: Stryker Universal Select Sterilization Tray System (Apr 18, 2018)
- K152951: Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray (Dec 28, 2015)
- K032119: Paragon Medical Surgical Instrument Delivery System Various (Oct 29, 2003)

Source page: https://510kreport.com/company/paragon-medical