# K191949: UNFOLDER Vitan Inserter

- Pathway: 510(k) (Abbreviated)
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Sep 13, 2019 after 53 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081382 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081382: Duckworth & Kent, LTD., Implantation System, Model DK7786, Duckworth & Kent, Ltd. (2008) Summary page 5.

## Indications for use
The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.

Source page: https://510kreport.com/device/K191949
Methodology: https://510kreport.com/methodology