510(k) · Cleared
ClearedCompressor Nebulizer System, Model KN-9321
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K-Jump Health Co., Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jul 22, 2005 as substantially equivalent to K031908 (Med2000 S.R.L., 2004) after a 58-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Jul 22, 2005
- Review
- 58 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K870027 (1987). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK051365 Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009 · cites it directly0descendants
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) | K051365 | Compressor Nebulizer System, Model KN-9321 | K-Jump Health Co., Ltd. | 2005 | — |
| +1 | K083256 | Ultrasonic Nebulizer System, Model KN-9210 | K-Jump Health Co., Ltd. | 2009 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Summary page 3…is substantially equivalent to the Med2000 Model, P1, P2 with Andyflow Nebulizer, K031908, Med20O0 SpA. This predicate device was cleared with similar indications for use as our proposed subject device indicatio… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083256 | Ultrasonic Nebulizer System, Model KN-9210 | 2009 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K083256 (K-Jump Health Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031908.
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?
K-jump Health Co, Ltd. Compressor Nebulizer System includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051365: Compressor Nebulizer System, Model KN-9321.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051365
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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