# K080299: Respifit S, Model RS-LR1001004

- Pathway: 510(k) (Traditional)
- Applicant: Eumedics Medizintechnik Und Marketing GmbH
- Decided: Jan 13, 2009 after 343 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: 1 generation back to K842634 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842634: Pflex Respiratory Muscle Exerciser, Health Scan, Inc. (1984) Summary page 1.
- K945118: Expiratory Breathing Exerciser, Dhd Diemolding Healthcare Div. (1995) Summary page 1.
- K870514: Threshold (TM) Inspiratory Muscle Trainer, Health Products, Inc. (1987) Summary page 1.
- K031102: Microlab Spirometer, Micro Direct, Inc. (2003) Summary page 1.

## Indications for use
The Respifit S is indicated for use as a training device used for conducting strength and endurance training by breathing into a patient module that contains an aperture. The purpose of this training is to improve inspiratory muscle strength and endurance. Training with the Respifit S can be performed in adults and patients with neuromuscular disease and cystic fibrosis in the hospital, clinic and home.

Source page: https://510kreport.com/device/K080299
Methodology: https://510kreport.com/methodology