510(k) · Cleared
ClearedBoeing, Positive Airway Pressure (Pap) Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dhd Healthcare Corp. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Jul 12, 1999 as substantially equivalent to K962749 (Diemolding Corp., 1996) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1995. 2 of the 14 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944900 (1995). 2 ancestors in all. 11 later devices descend from it, 3 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- This deviceK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- Descendant · cites it directly · 7 of its ownK051964 PowernebComedica, Inc. · 2005
- Descendant · 2 generations on · 6 of its ownK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- Descendant · 2 generations on · 5 of its ownK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- Descendant · 3 generations on · 4 of its ownK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K051964PowernebComedica, Inc. · 2005 · cites it directly7descendants
- K124032MetanebHill-Rom Services Pte, Ltd. · 2013 · 2 generations on6descendants
- K151689MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016 · 2 generations on5descendants
- K192143Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 3 generations on4descendants
- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944900 | Therapep | Dhd Diemolding Healthcare Div. | 1995 | — |
| 0 (this device) | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| +1 | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| +2 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| +2 | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| +3 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +4 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 2 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
2 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K962749 | Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask…Summary page 1…e: Boeing (final name tbd) b. Common name: Positive Airway Pressure (PAP) Device c. Classification name: Incentive Spirometer - 868.5690 3. Predicate Device: TheraPEP®, K962749, K944900 DHD Healthcare Corporation 125 Rasbach Street Canastota, NY 13032 4. Device Description The DHD Boeing is a single-pati… | 1996 |
| * | K944900 | TherapepSummary page 1…(final name tbd) b. Common name: Positive Airway Pressure (PAP) Device c. Classification name: Incentive Spirometer - 868.5690 3. Predicate Device: TheraPEP®, K962749, K944900 DHD Healthcare Corporation 125 Rasbach Street Canastota, NY 13032 4. Device Description The DHD Boeing is a single-patient-use R… | 1995 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Boeing is indicated for the treatment and prevention of atelectasis. Boeing facilitates opening of airways in patients requiring prevention or treatment of atelectasis. Boeing also has the ability to provide supplemental oxygen when used with compressed oxygen.
Patients requiring therapy for treatment and prevention of atelectasis who are capable of following directions for Positive Airway Pressure (PAP) therapy.
3.1. Labeling reflects the statement: “Federal (USA) Law restricts this device to sale by or on the order of a physician.”
3.2. Boeing is intended for use in a hospital.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991300: Boeing, Positive Airway Pressure (Pap) Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991300
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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