# NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable

- Device class: 2; regulation: 21 CFR 874.3620; FDA's rule: 510(k) required
- FDA decisions: 16
- 510(k) review time 2021–2025: median 314 days (middle half 226–381)
- Recalls: 1 (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)
- 2010: 1
- 2012: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2019: 2
- 2022: 1
- 2023: 1
- 2024: 1
- 2026: 2

## Most-cited predicates
- K012769: Macropore Ent Reconstruction Film (2001), cited by 2
- K233569: SeptAlign (2024), cited by 1
- K223167: Spirair Nasal Septal Strap (2023), cited by 1
- K161191: Latera Absorbable Nasal Implant (2016), cited by 1
- K251790: SeptAlign (2026), cited by 1
- K152958: INEX Absorbable Nasal Implant (2015), cited by 1
- K070886: Merogel Injectable Bioresorbable Stent (2007), cited by 1
- K092590: PDS Plates (2010), cited by 1
- K070715: Nasopore Ear (2007), cited by 1
- K132920: Spirox Inex Device (2014), cited by 1

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