# KHJ: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

- Device class: 2; regulation: 21 CFR 874.3620; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 268 days (middle half 268–268)
- 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)
- 2006: 3
- 2007: 1
- 2008: 3
- 2011: 1
- 2012: 2
- 2013: 2
- 2015: 1
- 2016: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K002972: Merogel Control Gel Ent Surgical Dressing (2000), cited by 4
- K001148: Merogel Otologic Pack (2000), cited by 4
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 (2002), cited by 4
- K062280: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste (2006), cited by 3
- K081531: Aoc Soluble Implant Material (2008), cited by 3
- K974311: Vocom (Vocal Cord Medialization) Implant (1998), cited by 2
- K970910: Xomed Silicone Block/Strip (1997), cited by 2
- K043035: Sepragel Ent Bioresorbable Packing/Stent (2005), cited by 2
- K051911: Gelita-Spon (2005), cited by 1
- K161000: Biodesign Otologic Repair Graft (2016), cited by 1

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