# NBC: Test, Natriuretic Peptide

- Device class: 2; regulation: 21 CFR 862.1117; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 266 days (middle half 245–452)
- Recalls: 9 (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)
- 2007: 2
- 2008: 7
- 2010: 1
- 2020: 1
- 2021: 2
- 2022: 1
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 4

## Most-cited predicates
- K022516: Elecsys Probnp Immunoassay (2002), cited by 9
- K032646: Elecsys Probnp Immunoassay (2003), cited by 8
- K021317: Triage B-Type Natriuretic Peptide (BNP) Test (2002), cited by 6
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset (2008), cited by 6
- K092649: Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160, 04842472-190 (2010), cited by 4
- K031038: Advia Centaur B-Type Natriuretic Peptide (BNP) Assay (2003), cited by 3
- K080578: Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge (K6423A), Dimension Vista (2008), cited by 3
- K051382: Elecsys Probnp Immunoassay (2005), cited by 3
- K051787: Triage BNP Test, Model 98000XR (2005), cited by 3
- K043476: Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent (2005), cited by 2

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