510(k) · Cleared
ClearedSalter Labs Modified Nebutech 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 Feb 1, 2002 as substantially equivalent to K961476 (Salter Labs, 1996) after a 53-day review. Its family tree reaches back 2 generations to 1987. 5 later devices descend from it.
- Decided
- Feb 1, 2002
- Review
- 53 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K870027 (1987). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
- 1 generation backK961476 Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Salter Labs · 1996 · Recalled
- This deviceK014056 Salter Labs Modified Nebutech NebulizerSalter Labs · 2002
- Descendant · cites it directly · 4 of its ownK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
- Descendant · 2 generations on · 1 of its ownK051365 Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005
- Descendant · 3 generations on · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK041974 MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004
- Descendant · 2 generations on · 0 of its ownK041327 MED2000 Spa Nebulizer Andyflow, Model A1/C with AccessoriesMed2000 S.R.L. · 2004
Most influential descendants
Showing 5 of 5 · See all- K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Med2000 S.R.L. · 2004 · cites it directly4descendants
- K051365Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005 · 2 generations on1descendant
- K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009 · 3 generations on0descendants
- K041974MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004 · 2 generations on0descendants
- K041327MED2000 Spa Nebulizer Andyflow, Model A1/C with AccessoriesMed2000 S.R.L. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| −1 | K961476 | Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984) | Salter Labs | 1996 | 1 |
| 0 (this device) | K014056 | Salter Labs Modified Nebutech Nebulizer | Salter Labs | 2002 | — |
| +1 | K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and… | Med2000 S.R.L. | 2004 | — |
| +2 | K051365 | Compressor Nebulizer System, Model KN-9321 | K-Jump Health Co., Ltd. | 2005 | — |
| +3 | K083256 | Ultrasonic Nebulizer System, Model KN-9210 | K-Jump Health Co., Ltd. | 2009 | — |
| +2 | K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer | Med2000 S.R.L. | 2004 | — |
| +2 | K041327 | MED2000 Spa Nebulizer Andyflow, Model A1/C with Accessories | Med2000 S.R.L. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K961476 | Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Summary page 1…ebulizer (trade name to be determined) Common Name is Nebulizer Classification Name: Nebulizer 3) Substantially equivalent to: Modification to the Ultramist Nebulizer, K961476. 4) Device Description and System Overview: The Salter Labs Modified Nebutech Nebulizer is a modification to the existing Salte… | 1996 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa… | 2004 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 9.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K031908 (Med2000 S.R.L., 2004) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K961476.
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?
This product is a nebulizer used to generate aerosols that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. This product is a single patient use, non-sterile prescription device and is designed to be used in either a hospital or homecare environment.
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/K014056 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014056: Salter Labs Modified Nebutech Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014056
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026