510(k) · Cleared
ClearedModel Irc 1001 Aerosol Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 27, 1999 as substantially equivalent to K914251 (Invacare Corp., 1992) and 1 other predicate after an 82-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Oct 27, 1999
- Review
- 82 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914251 (1992). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK914251 Model Irc Passport NebulizerInvacare Corp. · 1992
- This deviceK992643 Model Irc 1001 Aerosol CompressorInvacare Corp. · 1999
- Descendant · cites it directly · 0 of its ownK082878 Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008
- Descendant · cites it directly · 0 of its ownK062952 C300 Series Air Nebulizer CompressorChoice Smart Health Care Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK042655 Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456Respironics New Jersey, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K082878Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008 · cites it directly0descendants
- K062952C300 Series Air Nebulizer CompressorChoice Smart Health Care Co., Ltd. · 2007 · cites it directly0descendants
- K042655Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456Respironics New Jersey, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914251 | Model Irc Passport Nebulizer | Invacare Corp. | 1992 | — |
| 0 (this device) | K992643 | Model Irc 1001 Aerosol Compressor | Invacare Corp. | 1999 | — |
| +1 | K082878 | Nevoni Classic, Model 6600-PO | Nsr Comercio E Representacoes Ltda | 2008 | — |
| +1 | K062952 | C300 Series Air Nebulizer Compressor | Choice Smart Health Care Co., Ltd. | 2007 | — |
| +1 | K042655 | Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456 | Respironics New Jersey, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K914251 | Model Irc Passport NebulizerSummary page 3…age 3 === B. Substantial Equivalence The IRC 1001 Aerosol Compressor is substantially equivalent to Invacare Corporations’ Model IRC 1199 “Passport” Aerosol Compressor (K914251, January 24, 1992), and Medic- Aid Ltd. Model “Freeway Lite” Aerosol Compressor (K934749, July 25, 1994). Performance Data The… | 1992 |
| * | K934749 | Freeway Lite Nebulizer CompressorSummary page 3…uivalent to Invacare Corporations’ Model IRC 1199 “Passport” Aerosol Compressor (K914251, January 24, 1992), and Medic- Aid Ltd. Model “Freeway Lite” Aerosol Compressor (K934749, July 25, 1994). Performance Data The Madel TRC 1001 Aerosal Compressor was tested in accordance with the electrical, mechanica… | 1994 |
What descends from it? (3)
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?
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 Invacare Model IRC 1001 Aerosol Compressor is a prescription device designed for use in the treatment of respiratory disorders, such as asthma, in a household environment. Its intended use is to provide compressed air to a nebulizer for the generation of aerosolized medications, based on a physician’s prescription. Nebulizers are used to convert liquid medication to aerosol form for delivery to a patient through inhalation.
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/K992643 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992643: Model Irc 1001 Aerosol Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992643
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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