510(k) · Cleared
ClearedMED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C (Andyflow)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med2000 S.R.L. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jan 14, 2004 as substantially equivalent to K013027 (Respironics Healthscan, Inc., 2001) and 3 other predicates after a 208-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it.
- Decided
- Jan 14, 2004
- Review
- 208 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K870027 (1987). 6 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
- 2 generations backK961476 Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Salter Labs · 1996 · Recalled
- 1 generation backK014056 Salter Labs Modified Nebutech NebulizerSalter Labs · 2002
- This deviceK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
- Descendant · cites it directly · 1 of its ownK051365 Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK041974 MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004
- Descendant · cites it directly · 0 of its ownK041327 MED2000 Spa Nebulizer Andyflow, Model A1/C with AccessoriesMed2000 S.R.L. · 2004
Most influential descendants
Showing 4 of 4 · See all- K051365Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005 · cites it directly1descendant
- K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009 · 2 generations on0descendants
- K041974MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004 · cites it directly0descendants
- K041327MED2000 Spa Nebulizer Andyflow, Model A1/C with AccessoriesMed2000 S.R.L. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| −2 | K961476 | Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984) | Salter Labs | 1996 | 1 |
| −1 | K014056 | Salter Labs Modified Nebutech Nebulizer | Salter Labs | 2002 | — |
| 0 (this device) | K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and… | Med2000 S.R.L. | 2004 | — |
| +1 | K051365 | Compressor Nebulizer System, Model KN-9321 | K-Jump Health Co., Ltd. | 2005 | — |
| +2 | K083256 | Ultrasonic Nebulizer System, Model KN-9210 | K-Jump Health Co., Ltd. | 2009 | — |
| +1 | K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer | Med2000 S.R.L. | 2004 | — |
| +1 | K041327 | MED2000 Spa Nebulizer Andyflow, Model A1/C with Accessories | Med2000 S.R.L. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K013027 | Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123Summary page 1…ebulizer Compressor, Model P2, with Nebulizer 3. Med2000 SpA Nebulizer, Model Al/C (AndyFlow) with Accessories 3. Predicate Device Information: 1. K#013027, Mister Neb Tm Nebulizer Compressor, with Nebulizer, Model HS1 23, Respironics Healthscan, Inc., Cedar Grove, NJ… | 2001 |
| * | K961476 | Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Summary page 1…e Information: 1. K#013027, Mister Neb Tm Nebulizer Compressor, with Nebulizer, Model HS1 23, Respironics Healthscan, Inc., Cedar Grove, NJ 2. K#961476, Salter Labs Ultramist Nebulizer, 8960 Series, Salter Labs, Arvin, CA 3. K#014056, Salter Labs Modified Ultramis… | 1996 |
| * | K014056 | Salter Labs Modified Nebutech NebulizerSummary page 1…HS1 23, Respironics Healthscan, Inc., Cedar Grove, NJ 2. K#961476, Salter Labs Ultramist Nebulizer, 8960 Series, Salter Labs, Arvin, CA 3. K#014056, Salter Labs Modified Ultramist Nebulizer, Salter Labs, Arvin, CA 4. K#021742, Galemed Neb-Easy Nebulizer, Galemed Corp.,… | 2002 |
| * | K021742 | Galemed Neb-Easy NebulizerSummary page 1…Labs Ultramist Nebulizer, 8960 Series, Salter Labs, Arvin, CA 3. K#014056, Salter Labs Modified Ultramist Nebulizer, Salter Labs, Arvin, CA 4. K#021742, Galemed Neb-Easy Nebulizer, Galemed Corp., Temecula, CA… | 2002 |
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)
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 17 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K051365 (K-Jump Health Co., Ltd., 2005) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K013027.
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 Med2000 SpA Nebulizer Compressors, Models P1 and P2, are AC-powered air compressors, with adapter, intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model Al/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders…
Read the full statement (128 words)
The Med2000 SpA Nebulizer Compressors, Models P1 and P2, are AC-powered air compressors, with adapter, intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model Al/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.
The Med2000 SpA Nebulizer, Model Al/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031908: MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C (Andyflow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031908
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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