# K061102: Prima Anaesthesia Machine

- Pathway: 510(k) (Special)
- Applicant: Penlon, Ltd.
- Decided: Jul 28, 2006 after 100 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844008 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844008: Penlon AM1000 Anaesthesia Machine, Penlon, Inc. (1985) Summary page 1.
- K864590: AM1000, Bear Medical Systems, Inc. (1987) Summary page 1.

## Most influential descendants
- K132903: Dre Ventura (2014), 0 descendants of its own

## Recalls of this device
- Nov 29, 2011 · Not classified · Z-1318-2012: Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies.

## Indications for use
The Penlon Prima Anaesthesia Machine is designed to deliver a combination of medical gases and volatile anaesthetic agents to a breathing system.

Source page: https://510kreport.com/device/K061102
Methodology: https://510kreport.com/methodology