# Primeline Medical Products, Inc.

- Location (FDA's records): Edmonton, Alberta, CA
- FDA decisions: 9 (1997–2002): 9 510(k) clearances
- Product codes: KKX (3), FXX (3), FXP (1), FYA (1), EFQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Exact Medical Manufacturing, Inc.: 2 (https://510kreport.com/company/exact-medical-manufacturing)
- Primed Medical Products, Inc.: 1 (https://510kreport.com/company/primed-medical-products)
- Promedical Products Co., Ltd.: 1 (https://510kreport.com/company/promedical-products)
- Guangzhou Fortunique, Ltd.: 1 (https://510kreport.com/company/guangzhou-fortunique)
- Deroyal: 1 (https://510kreport.com/company/deroyal)

## Its most-cited devices
- K021864: Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142) (2002), cited by 2
- K023117: Primagard Surgical Gowns (2002), cited by 2
- K001951: Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306 (2000), cited by 1
- K022868: Primagard Surgical Equipment Drapes (2002), cited by 1

## Recent decisions
- K023117: Primagard Surgical Gowns (Nov 8, 2002)
- K023266: Primagard Surgical Gowns (Nov 8, 2002)
- K022868: Primagard Surgical Equipment Drapes (Nov 8, 2002)
- K021864: Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142) (Sep 23, 2002)
- K021076: Primagard Yellow Surgical Mask, Pleated, Tie-on, PM4-307; Primagard Yellow Surgical Mask, Pleated, Ear-Loop,PM4-308; PRM (Apr 16, 2002)
- K011789: Procedure Masks: PM4-301 and PM4-304 (Jun 22, 2001)
- K001951: Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306 (Sep 8, 2000)
- K971076: Primed Shoe Covers, Primed Head Covers (Jan 13, 1998)

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