510(k) · Cleared
Recalled · 2011Hand Held Pheumatic Powered (Disposable) Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Cleared on Mar 16, 1987 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled once.
- Decided
- Mar 16, 1987
- Review
- 70 days
- Class
- Class I
- Product code
- CCQ
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 6 citing it directly.
- This deviceK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987
- Descendant · cites it directly · 6 of its ownK961476 Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Salter Labs · 1996 · Recalled
- Descendant · 2 generations on · 5 of its ownK014056 Salter Labs Modified Nebutech NebulizerSalter Labs · 2002
- Descendant · 2 generations on · 4 of its ownK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
- Descendant · cites it directly · 4 of its ownK962879 Salterlabs 8660 Series NebulizerSalter Labs · 1996 · Recalled
- Descendant · 2 generations on · 1 of its ownK123527 AirlifeCare Fusion · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K961476Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Salter Labs · 1996 · cites it directly6descendants
- K014056Salter Labs Modified Nebutech NebulizerSalter Labs · 2002 · 2 generations on5descendants
- K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Med2000 S.R.L. · 2004 · 2 generations on4descendants
- K962879Salterlabs 8660 Series NebulizerSalter Labs · 1996 · cites it directly4descendants
- K123527AirlifeCare Fusion · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | — |
| +1 | K961476 | Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984) | Salter Labs | 1996 | 1 |
| +2 | K014056 | Salter Labs Modified Nebutech Nebulizer | Salter Labs | 2002 | — |
| +2 | K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and… | Med2000 S.R.L. | 2004 | — |
| +1 | K962879 | Salterlabs 8660 Series Nebulizer | Salter Labs | 1996 | 1 |
| +2 | K123527 | Airlife | Care Fusion | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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.
Planning a device in CCQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961476 | Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984) | 1996 | 6 |
| K962879 | Salterlabs 8660 Series Nebulizer | 1996 | 4 |
| K112824 | Quality Life Technologies Compressor Nebulizer | 2012 | 0 |
| K102454 | I-Neb Aad System with Tim; I-Neb Insight Aad System | 2011 | 0 |
| K072163 | Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 | 2008 | 0 |
| K962085 | Salter Labs 8990 Series Nebulizer | 1996 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2011 | Not classified | Z-0108-2012 | Equipment maintenance | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961476 (Salter Labs, 1996) has gone furthest, with 6 descendants of its own.
How does its category compare?
All CCQ devicesCCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCQ
FDA has decided no CCQ device since 2007.
Median 510(k) review, days · CCQ
Too few CCQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CCQ
5in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCQ
30in 2025
MAUDE reports naming product code CCQ, 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 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 207 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 132 |
| 2016 | 0 | — | 5 | 18 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K870027 · printed Nov 5, 2026
Cite this page
510(k) Report. “K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K870027
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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