510(k) · Cleared
ClearedVersaPAP Positive Airway Pressure (PAP) Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical International · BWF Spirometer, Therapeutic (Incentive)
Cleared on Aug 17, 2018 as substantially equivalent to K991300 (Dhd Healthcare Corp., 1999) after a 238-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Aug 17, 2018
- Review
- 238 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944900 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- 1 generation backK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- This deviceK173918 VersaPAP Positive Airway Pressure (PAP) DeviceTrudell Medical International · 2018
- Descendant · cites it directly · 0 of its ownK183108 Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International · 2019
Most influential descendants
Showing 1 of 1 · See all- K183108Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944900 | Therapep | Dhd Diemolding Healthcare Div. | 1995 | — |
| −1 | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| 0 (this device) | K173918 | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | 2018 | — |
| +1 | K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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 |
|---|---|---|---|
| * | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy DeviceSummary page 4…Regulatory Class II Product Code: BWF 3. Predicate Device Boeing, Positive Airway Pressure (PAP) Therapy Device, K991300 DHD Healthcare Corp DHD Healthcare Corp was purchased by Smith Medical. Smith Medical has changed the device name… | 1999 |
| † | K173825 | MC 300R* Nebulizer | 2018 |
| † | K150173 | Aerobika OPEP Devive with Manometer | 2015 |
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 |
|---|---|---|---|
| K183108 | Combined Aerobika OPEP and VersaPAP device | 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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 19.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183108 (Trudell Medical International, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K991300.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
VersaPAP* is indicated for the treatment and prevention of atelectasis. VersaPAP* also has the ability to provide supplemental oxygen when used with compressed oxygen. The VersaPAP* device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy in a hospital environment. The VersaPAP* device is a single patient, multiple use device intended to be used under the supervision of a healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173918: VersaPAP Positive Airway Pressure (PAP) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173918
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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