# K983317: Barron Microkeratome System, Model B2000

- Pathway: 510(k) (Traditional)
- Applicant: Barron Precision Instruments, LLC
- Decided: Dec 2, 1998 after 72 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: 3 generations back to K935342 (1994). 9 ancestors in all.
1 later device descends 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 2.
- K913697: Automatic Corneal Shaper, Hansa Research & Development, Inc. (1991) Summary page 2.
- K973294: Innovatome Microkeratome, Innovative Optics, Inc. (1997) Summary page 2.
- K903912: Keratome, Micro Precision Instrument Co. (1990) Summary page 2.

## Most influential descendants
- K991124: Visijet Hydrokeratome, Model 50 (2000), 0 descendants of its own

## Indications for use
The Barron Microkeratome System is indicated for performing lamellar sectioning of the cornea.

Source page: https://510kreport.com/device/K983317
Methodology: https://510kreport.com/methodology