# K981155: Flapmaker Disposable Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Hawken Industries
- Decided: Aug 14, 1998 after 136 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 K843646 (1985). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 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.
- K843646: Steinway Micro-Kerato-Trephine, Steinway Instrument Co., Inc. (1985)
- K913697: Automatic Corneal Shaper, Hansa Research & Development, Inc. (1991) Summary page 1.

## Most influential descendants
- K990900: Microkeratome, Model MK-2000 (1999), 2 descendants of its own
- K052891: Horizon Epikeratome Disposable Microkeratome System (2006), 0 descendants of its own
- K032297: Disposable N-PE Mickrokeratome Blades (2003), 0 descendants of its own
- K022205: Disposable N-PE Microkeratome Blades (2002), 0 descendants of its own

## Indications for use
The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.

Source page: https://510kreport.com/device/K981155
Methodology: https://510kreport.com/methodology