# Tuta Healthcare Pty Limited

- Location (FDA's records): Sydney Nsw, AU
- FDA decisions: 3 (2002–2002): 3 510(k) clearances
- Product codes: FPA (1), BRZ (1), HRX (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 4 (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 whose devices it cites most
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Edwards Orthopaedics Div., Baxter Healthcare Corp.: 1 (https://510kreport.com/company/edwards-orthopaedics-div-baxter-healthcare)

## Firms that cite its devices most
- Pentaferte S.P.A: 1 (https://510kreport.com/company/pentaferte)
- Lily Medical Supplies Co., Ltd.: 1 (https://510kreport.com/company/lily-medical-supplies)
- Analytica, Ltd.: 1 (https://510kreport.com/company/analytica)
- Maclin Power, Inc.: 1 (https://510kreport.com/company/maclin-power)

## Its most-cited devices
- K023595: Burette-in Line (150 ML) (2002), cited by 3
- K023039: Blood/Solution Administration Set, Model 33.015 (2002), cited by 1

## Recent decisions
- K023595: Burette-in Line (150 ML) (Dec 18, 2002)
- K023039: Blood/Solution Administration Set, Model 33.015 (Nov 7, 2002)
- K020083: Tuta Healthcare Arthroscopy Flushing Set, Model 80.601 (Feb 12, 2002)

Source page: https://510kreport.com/company/tuta-healthcare