# K864590: AM1000

- Pathway: 510(k) (Traditional)
- Applicant: Bear Medical Systems, Inc.
- Decided: May 4, 1987 after 164 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K061102: Prima Anaesthesia Machine (2006), 1 descendant of its own
- K132903: Dre Ventura (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K864590
Methodology: https://510kreport.com/methodology