# K103434: 3B Flex-Lite

- Pathway: 510(k) (Traditional)
- Applicant: 3B Products, LLC
- Decided: Oct 13, 2011 after 324 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- 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: 6 generations back to K982530 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022465: Modification to Nasal-Aire, Innomed Technologies (2003) Summary page 3.
- K090244: Swift FX, Resmed, Ltd. (2009) Summary page 2.

## Indications for use
1. To be used by adult patients (>661b /30kg); 2. To be used for single-patient reuse in the home environment Or multi-patient reuse in the hospital/institutional environment; 3. To be used in the following environments: Home, Hospital, and sub-acute institutions

Source page: https://510kreport.com/device/K103434
Methodology: https://510kreport.com/methodology