510(k) · Cleared
ClearedGalemed Neb-Easy Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galemed Corp. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 25, 2002 after a 150-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 150 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
6 later devices descend from it, 2 citing it directly.
- This deviceK021742 Galemed Neb-Easy NebulizerGalemed Corp. · 2002
- Descendant · cites it directly · 4 of its ownK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
- Descendant · 2 generations on · 1 of its ownK051365 Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005
- Descendant · 3 generations on · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK053490 Merits Health Products Portable NebulizerMerits Health Products Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK041974 MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Med2000 S.R.L. · 2004 · cites it directly4descendants
- K051365Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005 · 2 generations on1descendant
- K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009 · 3 generations on0descendants
- K053490Merits Health Products Portable NebulizerMerits Health Products Co., Ltd. · 2006 · cites it directly0descendants
- K041974MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021742 | Galemed Neb-Easy Nebulizer | Galemed Corp. | 2002 | — |
| +1 | K031908 | MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and… | Med2000 S.R.L. | 2004 | — |
| +2 | K051365 | Compressor Nebulizer System, Model KN-9321 | K-Jump Health Co., Ltd. | 2005 | — |
| +3 | K083256 | Ultrasonic Nebulizer System, Model KN-9210 | K-Jump Health Co., Ltd. | 2009 | — |
| +1 | K053490 | Merits Health Products Portable Nebulizer | Merits Health Products Co., Ltd. | 2006 | — |
| +2 | K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer | Med2000 S.R.L. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K883968 | FDA’s K883968 is Tenderfoot Our reading of the summary gave K883968, FDA’s number for Tenderfoot (International Technidyne Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Allegiance Misty-Neb Nebulizer”. Kept off the family tree. Summary page 1…Proprietary Name: Neb-Easy Nebulizer Common Name is Nebulizer Classification Name: Nebulizer 3) Substantially equivalent to: Allegiance Misty-Neb Nebulizer (K883968). 4) Device Description and System Overview: General Description of the Device: The nebulizer is a de… | 1988 |
What descends from it? (6)
2 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, K031908 (Med2000 S.R.L., 2004) has gone furthest, with 4 descendants of its own.
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 GaleMed Neb-Easy Nebulizer is a pneumatic nebulizer which nebulizes
specific drugs for inhalation by a patient. It is for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021742 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021742: Galemed Neb-Easy Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021742
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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