510(k) · Cleared
ClearedRespifit S, Model RS-LR1001004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eumedics Medizintechnik Und Marketing GmbH · BWF Spirometer, Therapeutic (Incentive)
Cleared on Jan 13, 2009 as substantially equivalent to K842634 (Health Scan, Inc., 1984) and 3 other predicates after a 343-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jan 13, 2009
- Review
- 343 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K842634 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK842634 Pflex Respiratory Muscle ExerciserHealth Scan, Inc. · 1984
- This deviceK080299 Respifit S, Model RS-LR1001004Eumedics Medizintechnik Und Marketing GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842634 | Pflex Respiratory Muscle Exerciser | Health Scan, Inc. | 1984 | — |
| 0 (this device) | K080299 | Respifit S, Model RS-LR1001004 | Eumedics Medizintechnik Und Marketing GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BWF device
- #1 K241152 InSeescore 9.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K842634 | Pflex Respiratory Muscle ExerciserSummary page 1…imed Device Manufacturer 510(k) Number PFLEX RESPIRATORY Healthscan K842634 MUSCLE EXERCISER EXPIRATORY DHD Diemolding K945118 BREATHING EXERCISER… | 1984 |
| * | K945118 | Expiratory Breathing ExerciserSummary page 1…RESPIRATORY Healthscan K842634 MUSCLE EXERCISER EXPIRATORY DHD Diemolding K945118 BREATHING EXERCISER Healthcare THRESHOLD(TM) Health Products, Inc.… | 1995 |
| * | K870514 | Threshold (TM) Inspiratory Muscle TrainerSummary page 1…DHD Diemolding K945118 BREATHING EXERCISER Healthcare THRESHOLD(TM) Health Products, Inc. K870514 INSPIRATORY MUSCLE TRAINER MICROLAB SPIROMETER Micro-Direct, Inc K031102 Devic… | 1987 |
| * | K031102 | Microlab SpirometerSummary page 1…Health Products, Inc. K870514 INSPIRATORY MUSCLE TRAINER MICROLAB SPIROMETER Micro-Direct, Inc K031102 Device Description The Respifit S is a portable device for training the respiratory muscles for strength… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWF
281in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BWF
3in 2025
MAUDE reports naming product code BWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 3 | 105 | 0 | 5 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 3 | 149 | 0 | 6 |
| 2017 | 3 | 136 | 0 | 7 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 3 | 281 | 0 | 16 |
| 2020 | 1 | — | 1 | 5 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080299 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080299: Respifit S, Model RS-LR1001004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080299
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026