# HAE: Rongeur, Manual

- Device class: 2; regulation: 21 CFR 882.4840; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 238 days (middle half 132–371)
- Recalls: 2 (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)
- 2013: 2
- 2015: 1
- 2016: 4
- 2018: 1
- 2020: 2
- 2021: 1
- 2022: 2
- 2023: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K092227: Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs (2010), cited by 6
- K150428: Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs (2015), cited by 5
- K153243: Fehling-Punches (2016), cited by 5
- K080494: Baxano Ultra Low Profile Rongeur (2008), cited by 3
- K200768: Rebellion, Phantom Multi-Bite Kerrison Rongeur (2021), cited by 2
- K081651: Instrumed Rongeur (2008), cited by 2
- K062711: Ultra Low Profile Rongeur (2007), cited by 2
- K100958: Modification to: Microblade Shaver and Accessories (2010), cited by 2
- K063231: Microblade Shaver and Accessories (2007), cited by 2
- K150468: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (2016), cited by 1

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