# K022637: BD-3000 Microkeratome System, Model K-3000 Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Oct 16, 2002 after 69 days
- Product code: HMY (Keratome, Battery-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984537 (1999). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K984537: Keratome System, Model K3000, Insight Technologies Instruments, LLC (1999) Summary page 3.
- (no number) Microkeratome Blade with Holder for ITI Keratome System: named in the summary without a submission number

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

## Recalls of this device
- Jan 24, 2003 · Not classified · Z-0634-03: Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.

## Indications for use
The BD K-3000TM Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as in Laser In-situ Keratomileusis (LASIK) surgery. The corneal resection is consistently of a predetermined diameter, thickness and uniform surface quality for precise lamellar cuts and consistent flap generation.

Source page: https://510kreport.com/device/K022637
Methodology: https://510kreport.com/methodology