510(k) Report

FDA applicant

Primary Care Solutions, Inc.

Zephyrhills, FL4 decisions2001–200827 recalls

FDA records 4 decisions for Primary Care Solutions, Inc. (Zephyrhills, FL) from 2001 to 2008: 4 510(k) clearances. Most are in product codes JOL (Catheter And Tip, Suction) and FRO (Dressing, Wound, Drug). Its devices cite 3 predicates, 2 of them its own earlier devices. 27 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Primary Care Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2023

2016: 252023: 2, 2 Class I
2007high 25 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Primary Care Solutions, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOLCatheter And Tip, Suction2decisions
  • FRODressing, Wound, Drug1decision
  • EZLCatheter, Retention Type, Balloon1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082330Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc. · 20083cite it
  • K030813Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog…Primary Care Solutions, Inc. · 20032cite it
  • K000265Primary Care Solutions Sterile Water Device IrrigationPrimary Care Solutions, Inc. · 20011cites it
  • K000266Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device IrrigationPrimary Care Solutions, Inc. · 20011cites it

What has FDA decided for it lately?

  • K082330Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc. · 2008
  • K030813Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog…Primary Care Solutions, Inc. · 20032 Class I recalls
  • K000265Primary Care Solutions Sterile Water Device IrrigationPrimary Care Solutions, Inc. · 2001
  • K000266Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device IrrigationPrimary Care Solutions, Inc. · 2001

All 4 as Primary Care Solutions, Inc. →

What has been recalled?

27 recalls linked to its devices; the latest:

  • K030813Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE…Nov 6, 2023Class I
  • K2012860.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL…Nov 6, 2023Class I
  • K100603Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes…Jan 22, 2016Class II
  • K100603Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are…Jan 22, 2016Class II
  • K100603Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are…Jan 22, 2016Class II
  • K100603Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes…Jan 22, 2016Class II

Other applicant names beginning “Primary”

FDA records each applicant name separately; these may or may not be the same firm.

Primary Technology, LLC 2