# K082043: Carriazo-Pendular Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Schwind Eye-Tech-Solutions GmbH & Co. KG
- Decided: Aug 1, 2008 after 14 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: 5 generations back to K935342 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032910: Carriazo Pendular, Schwind Eye-Tech-Solutions GmbH & Co. KG (2004) Summary page 1.
- K023092: BD K-4000 Microkeratome System, Becton, Dickinson & CO (2002) Summary page 1.
- K041893: Intralase FS Laser, Intra Lase Corp. (2005)

## Indications for use
The Carriazo Pendular Microkeratome indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

Source page: https://510kreport.com/device/K082043
Methodology: https://510kreport.com/methodology