# K980675: Summit Krumeich-Barraquer Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Summit Technology, Inc.
- Decided: Dec 22, 1998 after 305 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954058 (1995). 1 ancestor in all.
62 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)
- K954058: Barraquer-Krumeich Refractive Set, Eyetech M.V.A. (1995) Summary page 2.

## Most influential descendants
- 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
- K073404: Ifs Laser System (2008), 56 descendants of its own

## Recalls of this device
- Nov 18, 2002 · Not classified · Z-0612-03: Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.

## Indications for use
Keratoplasty & corneal harvesting Microlamellar keratoplasty

Source page: https://510kreport.com/device/K980675
Methodology: https://510kreport.com/methodology