510(k) · Cleared
ClearedPowerneb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comedica, Inc. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Dec 1, 2005 as substantially equivalent to K895485 (Percussionaire Corp., 1989) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 1995. 2 of the 12 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Dec 1, 2005
- Review
- 134 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944900 (1995). 4 ancestors in all, the oldest K895485 (1989). 7 later devices descend from it, 2 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- 1 generation backK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- This deviceK051964 PowernebComedica, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK231728 BiWaze Clear SystemAbmrc, LLC · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K124032MetanebHill-Rom Services Pte, Ltd. · 2013 · cites it directly6descendants
- K151689MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016 · cites it directly5descendants
- K192143Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 2 generations on4descendants
- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 3 generations on3descendants
- K231728BiWaze Clear SystemAbmrc, LLC · 2024 · 4 generations on1descendant
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) | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| +1 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| +1 | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| +2 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +3 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +4 | K231728 | BiWaze Clear System | Abmrc, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 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 NHJ device
- #1 K260604 BiWaze Clear Systemscore 14.0 · 8 generations · 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 |
|---|---|---|---|
| * | K895485 | Bird (Ipv) Noncontinuous VentilatorsSummary page 1…The PowerNeb® Noncontinuous Ventilator is substantially equivalent to the following devices: Bird (IPV) Noncontinuous Ventilator, marketed by Percussionaire Corp. under K895485 and the EZ Pap, marketed by DHD Healthcare Corp. under K99 1300. Comparative pre-set percussive frequency is equivalent to the Vo… | 1989 |
| * | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy DeviceSummary page 1…ent to the following devices: Bird (IPV) Noncontinuous Ventilator, marketed by Percussionaire Corp. under K895485 and the EZ Pap, marketed by DHD Healthcare Corp. under K99 1300. Comparative pre-set percussive frequency is equivalent to the Vortran PercussiveNEB, marketed under K003684 (which was found to… | 1999 |
| † | K003684 | Percussiveneb, Model PN-2001 | 2001 |
What descends from it? (7)
2 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K124032 (Hill-Rom Services Pte, Ltd., 2013) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K895485.
How does its category compare?
All NHJ devicesNHJ Device, Positive Pressure Breathing, Intermittent: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHJ
190in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHJ
11so far in 2026, the most since 2007
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · NHJ
35in 2025
MAUDE reports naming product code NHJ, 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 | 0 | — | 0 | 16 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 207 | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 3 | 190 | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 1 | — | 1 (1) | 40 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 2 | — | 11 (4) | — |
What is it indicated for?
PowerNeb® is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051964: Powerneb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051964
Report an extraction error
Are you the manufacturer?
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