# K913626: Softrans Injector

- Pathway: 510(k) (Traditional)
- Applicant: Staar Surgical Co.
- Decided: Dec 18, 1991 after 125 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K970033: Monarch Iol Delivery System (1997), 0 descendants of its own
- K965185: Acrypak Folder (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K913626
Methodology: https://510kreport.com/methodology