# K123896: CCS-200 Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Benson Medical Instruments Co.
- Decided: Sep 10, 2013 after 266 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 K944762 (1994). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090034: Easy on-PC Spirometer, Ndd Medizitechnik AG (2009) Summary page 1.
- K993921: NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001, Ndd Medical Technologies (2000) Summary page 1.

## Most influential descendants
- K130322: SPM-300 (2013), 3 descendants of its own
- K220535: Cardio10 (2022), 2 descendants of its own
- K231160: Cardio Q50, Cardio Q70 (2023), 0 descendants of its own
- K231150: Cardio P1 (2023), 0 descendants of its own

## Indications for use
The CCS-200 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients who are at least 16 years old, In general practice, specialty physician, industrial, and hospital settings.

Source page: https://510kreport.com/device/K123896
Methodology: https://510kreport.com/methodology