# Ballard Medical Products

- Location (FDA's records): Draper, UT
- FDA decisions: 26 (1982–2003): 26 510(k) clearances
- Product codes: BSY (5), GEC (2), BSP (2), KNT (2), FXX (1), BWH (1), CAH (1), FPA (1), KPJ (1), KDH (1), BYE (1), BTO (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 13 (1 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medical Innovations Corp.: 2 (https://510kreport.com/company/medical-innovations)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Tri-Med Specialties, Inc.: 1 (https://510kreport.com/company/tri-med-specialties)
- Tri-Med, Inc.: 1 (https://510kreport.com/company/tri-med)
- Wiltek Medical, Inc.: 1 (https://510kreport.com/company/wiltek-medical)

## Firms that cite its devices most
- Mallinckrodt Dar S.R.L.: 3 (https://510kreport.com/company/mallinckrodt-dar)
- Kimberly-Clark Corp.: 2 (https://510kreport.com/company/kimberly-clark)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Entracare Corp.: 1 (https://510kreport.com/company/entracare)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)
- Smiths Medical Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Plastimed Laboratoire Pharmaceutique: 1 (https://510kreport.com/company/plastimed-laboratoire-pharmaceutique)
- Mill-Rose Laboratory: 1 (https://510kreport.com/company/mill-rose-laboratory)

## Its most-cited devices
- K923487: Bal Cath (1993), cited by 4
- K000495: Ballard Medical Products Epidural and Spinal Needles (2000), cited by 2
- K993138: Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit (1999), cited by 2
- K974630: 72 Hour Use Trach Care with Microban (1998), cited by 1
- K951533: Easi-Lav Pediatric / Adult Gastric Lavage Kit (1995), cited by 1
- K964369: Trach Care Set with Microban (1997), cited by 1

## Recent decisions
- K030721: Quick-Tap Paracentesis Tray, Kit & Needle (Mar 31, 2003)
- K022398: Reusable Bronchial Biopsy Forceps (Oct 11, 2002)
- K013892: Lutz Needle (Jul 11, 2002)
- K000495: Ballard Medical Products Epidural and Spinal Needles (Mar 28, 2000)
- K993138: Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit (Oct 20, 1999)
- K990376: Ballard Medical Products Faciletome Bow String Papillotome (May 3, 1999)
- K982894: Mic-Key Glow Profile Gastrostomy Replacement Kit (Sep 11, 1998)
- K974630: 72 Hour Use Trach Care with Microban (Mar 11, 1998)

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