# K120880: ORBIT

- Pathway: 510(k) (Special)
- Applicant: National Biomedical, LLC Dba Qrs Diagnostic
- Decided: Apr 19, 2012 after 27 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- 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 K932278 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973138: Spirocard, Qrs Diagnostic, LLC (1998) Summary page 1.

## Indications for use
* Device Functionality: Spirometry * Primary Spirometric Parameters: FVC, MVV, SVC and FEF * Patient Population: Male/Female, Pediatric to Adult * Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use) The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purpose of assisting clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.

Source page: https://510kreport.com/device/K120880
Methodology: https://510kreport.com/methodology