510(k) · Cleared
Recalled · Class II · 2015Salterlabs 8660 Series Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 22, 1996 as substantially equivalent to K870027 (Salter Labs, 1987) after a 90-day review. Its family tree reaches back 1 generation to 1987. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 22, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- CAF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870027 (1987). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
- This deviceK962879 Salterlabs 8660 Series NebulizerSalter Labs · 1996
- Descendant · cites it directly · 1 of its ownK123527 AirlifeCare Fusion · 2013
- Descendant · 2 generations on · 0 of its ownK230602 Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023
- Descendant · cites it directly · 0 of its ownK080969 Healthline Redi-Neb Medication Nebulizer, Model RN-510Medi Nuclear Corp., Inc. · 2008
- Descendant · cites it directly · 0 of its ownK062484 Flaem Nuova RF6 Basic and RF6 Plus NebulizersFlaem Nuova S.P.A. · 2007
Most influential descendants
Showing 4 of 4 · See all- K123527AirlifeCare Fusion · 2013 · cites it directly1descendant
- K230602Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP · 2023 · 2 generations on0descendants
- K080969Healthline Redi-Neb Medication Nebulizer, Model RN-510Medi Nuclear Corp., Inc. · 2008 · cites it directly0descendants
- K062484Flaem Nuova RF6 Basic and RF6 Plus NebulizersFlaem Nuova S.P.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| 0 (this device) | K962879 | Salterlabs 8660 Series Nebulizer | Salter Labs | 1996 | — |
| +1 | K123527 | Airlife | Care Fusion | 2013 | — |
| +2 | K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023 | — |
| +1 | K080969 | Healthline Redi-Neb Medication Nebulizer, Model RN-510 | Medi Nuclear Corp., Inc. | 2008 | — |
| +1 | K062484 | Flaem Nuova RF6 Basic and RF6 Plus Nebulizers | Flaem Nuova S.P.A. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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 CAF? 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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · 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 |
|---|---|---|---|
| * | K870027 | Hand Held Pheumatic Powered (Disposable) NebulizerSummary page 1…eries 15.5 Identification of Predicate Device: Salter Labs Hand Held Pneumatic Powered (disposable) Nebulizer Model 8900, which was cleared for marketing by 510(k) No, K870027. 15.6 Description of the Device: Each of the Salter Labs 8660 Series Nebulizers consists of a Nebulizer Top which is screwed on… | 1987 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2015 | Class II | Z-2781-2015 | Component change control | The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Model 8660 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a reusable single patient use device (whereas the 8900 is a disposable single patient use device) which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not…
Read the full statement (122 words)
The Model 8660 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a reusable single patient use device (whereas the 8900 is a disposable single patient use device) which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile, although it must be cleaned or disinfected per the label instructions before reuse. The device is for single patient use. It is intended to be used with accessories, such tubing which is an industry standard device used with nebulizers.
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/K962879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962879: Salterlabs 8660 Series Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962879
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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