# K002837: Bis Engine

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Sep 19, 2000 after 7 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
307 later devices descend from it; 1 cites it directly.
0 of 308 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011834: Bis Engine (2001), 306 descendants of its own
- K012466: Bis/Eeg Module (2001), 305 descendants of its own
- K031694: Modification to Eeg Monitor with Bis, Model a-2000 (2003), 304 descendants of its own
- K030267: Eeg Monitor with Bis, Model a-2000 (2004), 303 descendants of its own
- K040183: BISX (2004), 274 descendants of its own

Source page: https://510kreport.com/device/K002837
Methodology: https://510kreport.com/methodology