# K993921: NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001

- Pathway: 510(k) (Traditional)
- Applicant: Ndd Medical Technologies
- Decided: May 23, 2000 after 187 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: 1 generation back to K944762 (1994). 1 ancestor in all.
10 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944762: Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data Managementsoftware, Puritan Bennett Corp. (1994). Our OCR of the scanned summary read K944672, FDA’s number for Insurg Laptie Needle Driver Suturing Devices (Boston Scientific Corp). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Puritan-Bennett Renaissance Spirometer”.

## Most influential descendants
- K123896: CCS-200 Spirometer (2013), 4 descendants of its own
- K130322: SPM-300 (2013), 3 descendants of its own
- K220535: Cardio10 (2022), 2 descendants of its own
- K161536: EasyOne Air Spirometer (2017), 1 descendant of its own
- K092813: Astrasonic Spirometer, Model 29-8000 (2010), 1 descendant of its own

## Indications for use
The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.

Source page: https://510kreport.com/device/K993921
Methodology: https://510kreport.com/methodology