# Primary Care Solutions, Inc.

- Location (FDA's records): Zephyrhills, FL
- FDA decisions: 4 (2001–2008): 4 510(k) clearances
- Product codes: JOL (2), FRO (1), EZL (1)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 27 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orion Life Systems, Inc.: 1 (https://510kreport.com/company/orion-life-systems)

## Firms that cite its devices most
- Amsino International, Inc.: 1 (https://510kreport.com/company/amsino-international)
- Inopro, Inc.: 1 (https://510kreport.com/company/inopro)
- Hangzhou Primecare Medical Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-primecare-medical)
- Oculus Innovative Sciences: 1 (https://510kreport.com/company/oculus-innovative-sciences)
- Premier Brands of America, Inc.: 1 (https://510kreport.com/company/premier-brands-of-america)

## Its most-cited devices
- K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation (2008), cited by 3
- K030813: Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and (2003), cited by 2
- K000265: Primary Care Solutions Sterile Water Device Irrigation (2001), cited by 1
- K000266: Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation (2001), cited by 1

## Recent decisions
- K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation (Oct 9, 2008)
- K030813: Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and (May 30, 2003)
- K000265: Primary Care Solutions Sterile Water Device Irrigation (Jul 12, 2001)
- K000266: Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation (Jul 12, 2001)

Source page: https://510kreport.com/company/primary-care-solutions