# HBA: Neurosurgical Paddie

- Device class: 2; regulation: 21 CFR 882.4700; FDA's rule: 510(k) required
- FDA decisions: 24
- Recalls: 29 (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)
- 1997: 3
- 2000: 1
- 2002: 2
- 2003: 1
- 2006: 1
- 2008: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2020: 1

## Most-cited predicates
- K993019: Pacific Surgical Patties (2000), cited by 2
- K880402: Codman Surgical Pattie (1988), cited by 2
- K962807: American Surgical Sponges/Neurosurgical Sponges (1997), cited by 1
- K031008: Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White) (2003), cited by 1
- K862494: Polyester Sponge Pattie (1986), cited by 1
- K902921: Rayon Neurological Sponge (1990), cited by 1

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