# DHB: System, Test, Radioallergosorbent (Rast) Immunological

- Device class: 2; regulation: 21 CFR 866.5750; FDA's rule: 510(k) required
- FDA decisions: 269
- 510(k) review time 2021–2025: median 240 days (middle half 137–386)
- Recalls: 21 (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)
- 2015: 1
- 2016: 2
- 2017: 1
- 2018: 2
- 2019: 3
- 2020: 2
- 2021: 1
- 2022: 2
- 2025: 2
- 2026: 6

## Most-cited predicates
- K051218: Modification to:  Unicap Specific Ige (2005), cited by 27
- K962274: Unicap 100 (1996), cited by 17
- K021208: Immulite 2000 Mixed Allergen Panels (2002), cited by 8
- K021206: Immulite 2000 Specific Allergens (2002), cited by 8
- K013134: Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests) (2001), cited by 8
- K013135: Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests) (2001), cited by 6
- K911903: Allergans Pharmacia Cap Sys.Rast Ria/Feia (1991), cited by 3
- K894190: Pharmacia Cap System Rast Ria & Rast Feia (1990), cited by 3
- K941278: HY-Tec Automated Eia System (1995), cited by 2
- K972068: Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 (1997), cited by 2

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