# K980951: Oneflow

- Pathway: 510(k) (Traditional)
- Applicant: Sti Medical
- Decided: Feb 25, 2000 after 714 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053156: Mini-Wright Digital, Model 3120001 (2006), 0 descendants of its own

## Indications for use
The STI OneFlow is a hand held, battery operated, electronic peak flow (PEFR) and FEV1 monitoring device with internal memory capable of storing 120 sets of readings. The product is available with or without software that downloads stored readings from the device and statistically analyzes this data as per criteria set in the patient information section of the program. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. This product will be sold as an OTC device with the appropriate FDA cautionary labeling. This product has been calibrated according to the American Thoracic Society “Standardization of Spirometry, 1994 Update”.

Source page: https://510kreport.com/device/K980951
Methodology: https://510kreport.com/methodology