# NLH: Catheter, Recording, Electrode, Reprocessed

- Device class: 2; regulation: 21 CFR 870.1220; FDA's rule: 510(k) required
- FDA decisions: 70
- 510(k) review time 2021–2025: median 141 days (middle half 120–191)
- Recalls: 37 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 11
- 2017: 4
- 2018: 4
- 2019: 4
- 2020: 2
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 6
- 2025: 2

## Most-cited predicates
- K012708: Electrophysiology Catheter (2002), cited by 5
- K012688: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (2002), cited by 2
- K012687: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (2002), cited by 2
- K193263: Reprocessed Achieve Catheter Connecting Cable (2020), cited by 1
- K081329: Reprocessed Electrophysiology Catheters (2008), cited by 1
- K161827: Reprocessed Response Diagnostic Electrophysiology Catheters (2016), cited by 1
- K161464: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters (2016), cited by 1
- K023180: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (2002), cited by 1
- K082023: Reprocessed Electrophysiology Catheters (2008), cited by 1
- K170922: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (2017), cited by 1

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