# K212763: UniVit HE, UniVit UHS

- Pathway: 510(k) (Traditional)
- Applicant: Visioncare Devices, LLC
- Decided: Aug 10, 2022 after 344 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896622 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120170: Procare Plus Vitrectomy System, Visioncare Devices, Inc. (2012) Summary page 4.

## Indications for use
The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.

Source page: https://510kreport.com/device/K212763
Methodology: https://510kreport.com/methodology