# P/L Biomedical

- Location (FDA's records): Fort Myers, FL
- FDA decisions: 3 (1997–2012): 3 510(k) clearances
- Product codes: FMI (2), FPA (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ypsomed AG: 2 (https://510kreport.com/company/ypsomed)

## Firms that cite its devices most
- Unomedical A/S: 5 (https://510kreport.com/company/unomedical-a-s)
- Ypsomed AG: 2 (https://510kreport.com/company/ypsomed)
- Sterling Medivations, Inc.: 1 (https://510kreport.com/company/sterling-medivations)
- Msr, Inc.: 1 (https://510kreport.com/company/msr)
- Medtronic Minimed: 1 (https://510kreport.com/company/medtronic-minimed)

## Its most-cited devices
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set (1997), cited by 8
- K122969: Clickfine Pen Needle (2012), cited by 1
- K122971: Clickfine Pen Needle (2012), cited by 1

## Recent decisions
- K122969: Clickfine Pen Needle (Oct 25, 2012)
- K122971: Clickfine Pen Needle (Oct 25, 2012)
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set (Aug 26, 1997)

Source page: https://510kreport.com/company/p-l-biomedical