# FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

- Device class: 2; regulation: 21 CFR 880.5200; FDA's rule: 510(k) required
- FDA decisions: 508
- 510(k) review time 2021–2025: median 134 days (middle half 82–231)
- Recalls: 235 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 9
- 2018: 1
- 2019: 8
- 2020: 10
- 2021: 4
- 2022: 8
- 2023: 9
- 2024: 6
- 2025: 11
- 2026: 7

## Most-cited predicates
- K032843: Nexiva Closed IV Catheter System (2004), cited by 8
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter (1990), cited by 8
- K020785: Introcan Safety IV Catheter (2002), cited by 8
- K102520: BD Nexiva Closed IV Catheter System (2011), cited by 7
- K013800: Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete (2001), cited by 7
- K110443: BD Insyte Autoguard BC (2011), cited by 7
- K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter (1999), cited by 6
- K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter (2000), cited by 6
- K971339: Insyte, Insyte-W, Insyte Autoguard Catheters (1997), cited by 6
- K982805: Introcan Safety IV Catheter (1999), cited by 5

Source page: https://510kreport.com/product-code/FOZ
Data by year (CSV): https://510kreport.com/product-code/FOZ.csv