# K984537: Keratome System, Model K3000

- Pathway: 510(k) (Traditional)
- Applicant: Insight Technologies Instruments, LLC
- Decided: May 14, 1999 after 144 days
- Product code: HMY (Keratome, Battery-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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022637: BD-3000 Microkeratome System, Model K-3000 Microkeratome (2002), 2 descendants of its own
- K023092: BD K-4000 Microkeratome System (2002), 1 descendant of its own
- K082043: Carriazo-Pendular Microkeratome (2008), 0 descendants of its own

## Indications for use
The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.

Source page: https://510kreport.com/device/K984537
Methodology: https://510kreport.com/methodology