510(k) · Cleared
ClearedUltrasonic Nebuliser Model 2010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilfred Kromker GmbH · CAF Nebulizer (Direct Patient Interface)
Cleared on Jul 15, 2008 as substantially equivalent to K872826 (The Devilbiss Co., 1987) after a 348-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jul 15, 2008
- Review
- 348 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872826 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872826 Ultra-Neb 99 Ultrasonic NebulizerThe Devilbiss Co. · 1987
- This deviceK072136 Ultrasonic Nebuliser Model 2010Wilfred Kromker GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872826 | Ultra-Neb 99 Ultrasonic Nebulizer | The Devilbiss Co. | 1987 | — |
| 0 (this device) | K072136 | Ultrasonic Nebuliser Model 2010 | Wilfred Kromker GmbH | 2008 | — |
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 |
|---|---|---|---|
| * | K872826 | Ultra-Neb 99 Ultrasonic NebulizerSummary page 1…siology Product Code: CAF Predicate Device: * Predicate Device: Ultra-Neb 99 Ultrasonic Nebulizer · 510K Number: K872826 · Manufacturer: DeVilbiss Healtcare, Somerset PA (division of Sunrise Medical… | 1987 |
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?
- Its one ancestor has no recall.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Kr6mker Medizintechnik Nebulizer Model Ultra-Neb 2010 is designed to aerosolize saline solution and liquid medication by ultrasonic energy. A single patient use medication cup is available for use with medications.
The device is intended for use on adult and pediatric patients who have been prescribed inhalation therapy, sputum induction, or medication for nebulization. The device is intended for use in hospitals, hospital-type facilities, nursing home, sub-acute institutions, and home environments.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072136: Ultrasonic Nebuliser Model 2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072136
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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