510(k) · Cleared
ClearedMED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med2000 S.R.L. · BTI Compressor, Air, Portable
Cleared on Aug 24, 2004 as substantially equivalent to K031908 (Med2000 S.R.L., 2004) after a 33-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Aug 24, 2004
- Review
- 33 days
- Class
- Class II
- Product code
- BTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K870027 (1987). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
- 3 generations backK961476 Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Salter Labs · 1996 · Recalled
- 2 generations backK014056 Salter Labs Modified Nebutech NebulizerSalter Labs · 2002
- 1 generation backK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
- This deviceK041974 MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| −3 | K961476 | Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984) | Salter Labs | 1996 | 1 |
| −2 | 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 | — |
| 0 (this device) | K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer | 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 |
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 BTI? 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? (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 |
|---|---|---|---|
| * | K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Summary page 1…ebulizer Compressor, Model P4, with Nebulizer 3. MED2000 SpA Nebulizer Compressor, Model P5, with Nebulizer 3. Predicate Device Information: K# 031908, Med2000 SpA Nebulizer Compressor, Models PI and P2, with Nebulizer, Med2000 SpA, Italy 4. Device Description:… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K031908.
How does its category compare?
All BTI devicesBTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · BTI
Too few BTI 510(k)s in any year since 2007 to give a median.
Recalls per year · BTI
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · BTI
120in 2025
MAUDE reports naming product code BTI, 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 | — | 1 | 18 |
| 2008 | 1 | — | 0 | 9 |
| 2009 | 1 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 217 |
| 2013 | 1 | — | 1 | 1,710 |
| 2014 | 0 | — | 0 | 982 |
| 2015 | 0 | — | 0 | 294 |
| 2016 | 0 | — | 0 | 139 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 0 | — | 0 | 114 |
| 2020 | 0 | — | 0 | 111 |
| 2021 | 0 | — | 0 | 278 |
| 2022 | 0 | — | 0 | 248 |
| 2023 | 0 | — | 3 (3) | 325 |
| 2024 | 0 | — | 0 | 166 |
| 2025 | 0 | — | 0 | 120 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Med2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, are AC-powered air compressors 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041974: MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041974
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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