510(k) · Cleared
ClearedTriball Incentive Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Besmed Health Business Corp · BWF Spirometer, Therapeutic (Incentive)
Cleared on Apr 4, 2014 as substantially equivalent to K781831 (Hudson Oxygen Therapy Sales Co., 1978) after a 105-day review. Its family tree reaches back 1 generation to 1978. 2 later devices descend from it.
- Decided
- Apr 4, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781831 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK781831 Spirometer, Incentive Catalog # 1750Hudson Oxygen Therapy Sales Co. · 1978
- This deviceK133873 Triball Incentive SpirometerBesmed Health Business Corp · 2014
- Descendant · cites it directly · 0 of its ownK220565 Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK160837 Medinet Incentive Spirometers - RespiprogramMedinet Srl · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781831 | Spirometer, Incentive Catalog # 1750 | Hudson Oxygen Therapy Sales Co. | 1978 | — |
| 0 (this device) | K133873 | Triball Incentive Spirometer | Besmed Health Business Corp | 2014 | — |
| +1 | K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | 2022 | — |
| +1 | K160837 | Medinet Incentive Spirometers - Respiprogram | Medinet Srl | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K781831 | Spirometer, Incentive Catalog # 1750Summary page 1…BWF - spirometer, therapeutic (incentive) Class 11 Predicate Devices: K781831 - Hudson RCI TriFlo Device Description: The Besmed TniBall Incentive Spirometer has a flexible tube and mouthpiece which the pat… | 1978 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K220565 (Medline Industries, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Besmed Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser.
Intended for single-patient, multi-use in a hospital or home care setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133873: Triball Incentive Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133873
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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