510(k) · Cleared
ClearedModel Irc Passport Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · LAW Theophylline Control Materials
Cleared on Jan 24, 1992 after a 123-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Jan 24, 1992
- Review
- 123 days
- Class
- Class I
- Product code
- LAW
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK914251 Model Irc Passport NebulizerInvacare Corp. · 1992
- Descendant · cites it directly · 6 of its ownK013027 Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123Respironics Healthscan, Inc. · 2001
- Descendant · 2 generations on · 4 of its ownK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
- Descendant · cites it directly · 3 of its ownK992643 Model Irc 1001 Aerosol CompressorInvacare Corp. · 1999
- Descendant · 3 generations on · 1 of its ownK051365 Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005
- Descendant · 4 generations on · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K013027Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123Respironics Healthscan, Inc. · 2001 · cites it directly6descendants
- K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Med2000 S.R.L. · 2004 · 2 generations on4descendants
- K992643Model Irc 1001 Aerosol CompressorInvacare Corp. · 1999 · cites it directly3descendants
- K051365Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005 · 3 generations on1descendant
- K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914251 | Model Irc Passport Nebulizer | Invacare Corp. | 1992 | — |
| +1 | K013027 | Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123 | Respironics Healthscan, Inc. | 2001 | — |
| +2 | K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and… | Med2000 S.R.L. | 2004 | — |
| +1 | K992643 | Model Irc 1001 Aerosol Compressor | Invacare Corp. | 1999 | — |
| +3 | K051365 | Compressor Nebulizer System, Model KN-9321 | K-Jump Health Co., Ltd. | 2005 | — |
| +4 | K083256 | Ultrasonic Nebulizer System, Model KN-9210 | K-Jump Health Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LAW? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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?
- Of its descendants, K013027 (Respironics Healthscan, Inc., 2001) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LAW devicesLAW Theophylline Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAW
FDA has decided no LAW device since 2007.
Median 510(k) review, days · LAW
Too few LAW 510(k)s in any year since 2007 to give a median.
Recalls per year · LAW
No recall names LAW since 2007.
Adverse event reports per year · LAW
No MAUDE report names LAW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K914251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914251: Model Irc Passport Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914251
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026