# K202391: DIR 800

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jan 21, 2021 after 153 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944261 (1994). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100468: Zeiss Infrared 800 with Flow 800 Option, Carl Zeiss Surgical GmbH (2010) Summary page 4.

## Most influential descendants
- K243077: Affirm 800 (2025), 0 descendants of its own

## Indications for use
The DIR 800 is an accessory for the Aesculap Aeos and is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency in neurosurgery. It also aids in the visual assessment of intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

Source page: https://510kreport.com/device/K202391
Methodology: https://510kreport.com/methodology