# K023354: Compressor Mini, 115 V, Model 64 81 779 EH81E

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Elema AB
- Decided: Sep 5, 2003 after 333 days
- Product code: BTI (Compressor, Air, Portable)
- Device class: 2
- Regulation: 21 CFR 868.6250
- 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 K951926 (1995). 1 ancestor in all.
51 later devices descend from it; 2 cite it directly.
19 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951926: Alreco 40400, Allan Rehnstrom AB (1995) Summary page 1.

## Most influential descendants
- K051895: GE Datex-Ohmeda Engstrom Carestation (2005), 49 descendants of its own
- K060862: GE Datex-Ohmeda Engstrom Carestation (2006), 48 descendants of its own
- K062710: GE Datex-Ohmeda Engstrom Carestation (2006), 47 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own
- K093886: Engstrom Carestation, Engstrom Pro (2010), 21 descendants of its own

## Recalls of this device
- Dec 5, 2013 · Class II · Z-0848-2014: Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

## Indications for use
The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Ymin at 50-64 psi (350 - 450 H a , 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital enhonment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.

Source page: https://510kreport.com/device/K023354
Methodology: https://510kreport.com/methodology