# Hakki Medical Technologies, Inc.

- Location (FDA's records): Pinellas Park, FL
- FDA decisions: 2 (2011–2020): 2 510(k) clearances
- Product codes: GBM (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)

## Its most-cited devices
- K101900: Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French (2011), cited by 1

## Recent decisions
- K191512: LotusCatheter (Lotus No Balloon Catheter) (May 21, 2020)
- K101900: Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French (Feb 7, 2011)

Source page: https://510kreport.com/company/hakki-medical-technologies