# K221014: Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Effortless Oxygen, LLC
- Decided: Oct 17, 2022 after 195 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933930 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090421: Model 350G Gas Conserver, Inspired Technologies, Inc. (2009) Summary page 4.

## Indications for use
The Effortless Oxygen Conserver Systems are intended to deliver medical-grade oxygen for patients that require supplemental oxygen from oxygen gas sources. Pulsing oxygen allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Effortless MOBILE may be used in hospital, healthcare facilities, or home care environments. The Effortless PRO is only intended for hospital and healthcare facilities under professional use.

Source page: https://510kreport.com/device/K221014
Methodology: https://510kreport.com/methodology