510(k) · Cleared
ClearedVolumetric Incentive Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Besmed Health Business Corporation · BWF Spirometer, Therapeutic (Incentive)
Cleared on Sep 3, 2014 as substantially equivalent to K801199 (Chesebrough-Pond'S U.S.A. Co., 1980) after a 103-day review. Its family tree reaches back 1 generation to 1980. 1 later device descends from it.
- Decided
- Sep 3, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K801199 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK801199 Voldyne Volumetric Incentive Deep BR. EXChesebrough-Pond'S U.S.A. Co. · 1980
- This deviceK141355 Volumetric Incentive SpirometerBesmed Health Business Corporation · 2014
- Descendant · cites it directly · 0 of its ownK182847 Hudson RCI Voldyne Volumetric ExerciserTeleflexmedical, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182847Hudson RCI Voldyne Volumetric ExerciserTeleflexmedical, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801199 | Voldyne Volumetric Incentive Deep BR. EX | Chesebrough-Pond'S U.S.A. Co. | 1980 | — |
| 0 (this device) | K141355 | Volumetric Incentive Spirometer | Besmed Health Business Corporation | 2014 | — |
| +1 | K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K801199 | Voldyne Volumetric Incentive Deep BR. EXSummary page 4…ion Name: 21CFR 868.5690, Class 2 BWF - spirometer, therapeutic (incentive) Predicate Devices: K801199 – Hudson RCI Voldyne Device Description: The Besmed Volumetric Incentive Spirometer has a flexible tube and mouthpiece which the… | 1980 |
| † | K133873 | Triball Incentive Spirometer | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | 2019 | 0 |
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, K182847 (Teleflexmedical, Inc., 2019) 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 Volumetric 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/K141355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141355: Volumetric Incentive Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141355
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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