# K974004: Automated Disposable Keratome (Adk)

- Pathway: 510(k) (Traditional)
- Applicant: Lasersight Technologies, Inc.
- Decided: Jan 8, 1998 after 79 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
Longest line of descent: 1 generation back to K860001 (1986). 3 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941550: Automatic Corneal Shaper Surgical Instrument, Chiron Vision Corp. (1994) Summary page 1.
- K860001: Barraquer-Krumeich Refractive Set, American Medical Optics (1986) Summary page 1.
- K903912: Keratome, Micro Precision Instrument Co. (1990) Summary page 1.

## Most influential descendants
- K981742: One UP Disposable Keratome Head (1998), 3 descendants of its own
- K040297: Oneuse- Plus Microkeratome (2004), 2 descendants of its own
- K990900: Microkeratome, Model MK-2000 (1999), 2 descendants of its own
- K043183: EPI-K (2005), 1 descendant of its own
- K983317: Barron Microkeratome System, Model B2000 (1998), 1 descendant of its own

## Indications for use
ADK (Automated Disposable Keratome) is intended to perform anterior, lameliar, circular corneal resections of a predetermined diameter and thickness.

Source page: https://510kreport.com/device/K974004
Methodology: https://510kreport.com/methodology