# HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

- Device class: 2; regulation: 21 CFR 886.1385; FDA's rule: 510(k) required
- FDA decisions: 41
- Recalls: 0 (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: 1
- 2001: 1
- 2002: 3
- 2003: 1
- 2004: 1
- 2005: 3
- 2014: 1
- 2015: 1
- 2018: 1
- 2020: 1

## Most-cited predicates
- K012096: Disposable Vitrectomy Lens (2001), cited by 5
- K943125: Quadraspheric Fundus Lens (1994), cited by 3
- K023221: Contact Laser & Diagnostic Lenses (2002), cited by 2
- K050623: Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D (2005), cited by 2
- K142715: Sensor Medical Family of Vitrectomy Lenses and Products (2014), cited by 1
- K151961: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (2015), cited by 1
- K872136: 12.5MM Peyman Wide Field Yag Laser Lens (1987), cited by 1
- K014170: Staurenghi Wide Field Scanning Laser Lens (2002), cited by 1
- K051103: Haag-Streit Contact Glasses Stery Cup, Accessory (2005), cited by 1

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