# K954058: Barraquer-Krumeich Refractive Set

- Pathway: 510(k) (Traditional)
- Applicant: Eyetech M.V.A.
- Decided: Nov 6, 1995 after 154 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
63 later devices descend from it; 1 cites it directly.
0 of 64 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
- K980675: Summit Krumeich-Barraquer Microkeratome (1998), 62 descendants of its own
- K013151: Asmotom Automated Trephine System (2001), 61 descendants of its own
- K041893: Intralase FS Laser (2005), 60 descendants of its own
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 (2006), 58 descendants of its own
- K063682: Intralase Fusion Laser (2007), 57 descendants of its own

Source page: https://510kreport.com/device/K954058
Methodology: https://510kreport.com/methodology