# K943125: Quadraspheric Fundus Lens

- Pathway: 510(k) (Traditional)
- Applicant: Volk Optical, Inc.
- Decided: Sep 2, 1994 after 65 days
- Product code: HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 886.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050623: Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism SSV D (2005), 2 descendants of its own
- K151961: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (2015), 1 descendant of its own
- K051103: Haag-Streit Contact Glasses Stery Cup, Accessory (2005), 1 descendant of its own
- K173944: Endocular Viewing Lenses and Silicone Ring (2018), 0 descendants of its own
- K052674: Contact Lens Ophthalmodynamometer (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K943125
Methodology: https://510kreport.com/methodology