# K992256: Frolov's Respiration Training Device, FRTD-01

- Pathway: 510(k) (Traditional)
- Applicant: Intercontinental New Technologies, Inc.
- Decided: Jan 11, 2000 after 189 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- 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 K944412 (1995). 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)
- K974848: Mini-Ciser, Hougen Mfg., Inc. (1998) Summary page 1.

## Indications for use
The device is for use as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device, for use by adults and children. The device is for single patient use, not for use on multiple patients.

Source page: https://510kreport.com/device/K992256
Methodology: https://510kreport.com/methodology