# K981742: One UP Disposable Keratome Head

- Pathway: 510(k) (Traditional)
- Applicant: Moria, Inc.
- Decided: Aug 25, 1998 after 99 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: 2 generations back to K935342 (1994). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974004: Automated Disposable Keratome (Adk), Lasersight Technologies, Inc. (1998) Summary page 1.
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories), Plancon Instruments (1997) Summary page 1.

## Most influential descendants
- K040297: Oneuse- Plus Microkeratome (2004), 2 descendants of its own
- K043183: EPI-K (2005), 1 descendant of its own
- K172994: EPI K Console (2017), 0 descendants of its own

## Indications for use
The ONE UP disposable keratome head is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

Source page: https://510kreport.com/device/K981742
Methodology: https://510kreport.com/methodology