# K000815: AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Jun 8, 2000 after 87 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 1 cites it directly.
1 of 57 devices in its family (counting itself) has 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
- K021279: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software (2002), 55 descendants of its own
- K030812: Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software (2003), 54 descendants of its own
- K051400: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options (2006), 48 descendants of its own
- K092027: Carescape Monitor B850 (2009), 38 descendants of its own
- K092680: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or F-CU5 (P) Monitor Frame Options an (2009), 33 descendants of its own

Source page: https://510kreport.com/device/K000815
Methodology: https://510kreport.com/methodology