# K972614: Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne Technologies, Inc.
- Decided: Jan 20, 1998 after 190 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061261: L4 Oxygen Concentrator (2006), 6 descendants of its own
- K043006: Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 (2005), 4 descendants of its own
- K061426: Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47 (2006), 2 descendants of its own
- K091363: Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, Bacteria Filter (2010), 1 descendant of its own
- K082566: Mark 5 Nuvo Lite Ocsi and STD (2008), 1 descendant of its own

## Indications for use
The Twister Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. This device is not intended to be life supporting nor life sustaining. The Twister produces concentrated oxygen from room air for delivery to a patient requiring low flow oxygen therapy. The oxygen from the air is concentrated using a molecular sieve and a pressure swing adsorption process.

Source page: https://510kreport.com/device/K972614
Methodology: https://510kreport.com/methodology