510(k) · Cleared
ClearedBird (Ipv) Noncontinuous Ventilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Percussionaire Corp. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Oct 30, 1989 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Oct 30, 1989
- Review
- 49 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK895485 Bird (Ipv) Noncontinuous VentilatorsPercussionaire Corp. · 1989
- Descendant · cites it directly · 7 of its ownK051964 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)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K051964PowernebComedica, Inc. · 2005 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895485 | Bird (Ipv) Noncontinuous Ventilators | Percussionaire Corp. | 1989 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
3 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?
- Of its descendants, K051964 (Comedica, Inc., 2005) has gone furthest, with 7 descendants of its own.
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) | — |
https://510kreport.com/device/K895485 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895485: Bird (Ipv) Noncontinuous Ventilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895485
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026