# K012096: Disposable Vitrectomy Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Instruments, Inc.
- Decided: Aug 24, 2001 after 50 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.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
- K142715: Sensor Medical Family of Vitrectomy Lenses and Products (2014), 1 descendant of its own
- K173944: Endocular Viewing Lenses and Silicone Ring (2018), 0 descendants of its own
- K051630: Super View Disposable Biom Lens Set (2005), 0 descendants of its own

## Indications for use
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

Source page: https://510kreport.com/device/K012096
Methodology: https://510kreport.com/methodology