# K200321: Novaerus NV1050

- Pathway: 510(k) (Traditional)
- Applicant: Novaerus Us, Inc.
- Decided: Dec 28, 2020 after 322 days
- Product code: FRF (Cleaner, Air, Medical Recirculating)
- Device class: 2
- Regulation: 21 CFR 880.5045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972064 (1997). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070722: Plasmair, Model T2006, Airinspace B.V. (2007) Summary page 4.

## Most influential descendants
- K211507: Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (2022), 1 descendant of its own
- K220298: CerroZone Mobile (2022), 1 descendant of its own
- K242102: CerroZone Mini (2024), 0 descendants of its own
- K240696: Airdog X8 Air Purifier (KJ800F-X8) (2024), 0 descendants of its own
- K220990: Qorda QD1 (2022), 0 descendants of its own

## Indications for use
The Novaerus NV 1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes.

Source page: https://510kreport.com/device/K200321
Methodology: https://510kreport.com/methodology