# LDR: Controller, Infusion, Intravascular, Electronic

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 120 days (middle half 74–165)
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1986: 5
- 1987: 3
- 1988: 7
- 1989: 3
- 1990: 1
- 1991: 2
- 1994: 2
- 1997: 3
- 2016: 1
- 2024: 2

## Most-cited predicates
- K896907: 3M IV Flow Regulator (1990), cited by 1
- K232316: DEKA Infusion System, DEKA Administration Set (2024), cited by 1
- K153760: Volumetric Infusion Controller (2016), cited by 1
- K863204: Deka JR. (1986), cited by 1
- K884307: Ivac (R) Volumetric Controller - Model 262 (1988), cited by 1

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