510(k) · Cleared
ClearedQuality Life Technologies Compressor Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Life Technologies Co;Ltd · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 21, 2012 as substantially equivalent to K931015 (Devilbiss Health Care, Inc., 1993) and 2 other predicates after a 267-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jun 21, 2012
- Review
- 267 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870027 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
- This deviceK112824 Quality Life Technologies Compressor NebulizerQuality Life Technologies Co;Ltd · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870027 | Hand Held Pheumatic Powered (Disposable) Nebulizer | Salter Labs | 1987 | 1 |
| 0 (this device) | K112824 | Quality Life Technologies Compressor Nebulizer | Quality Life Technologies Co;Ltd | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K931015 | Devilbiss Model 4650 Compressor NeubulizerSummary page 1…11 Classification Name: Nebulizer (direct patient interface) Regulation Number: 21 CFR 868.5630 Product Code: OAF Review Panel: Anesthesiology Predicate Device: K931015, DEVILBISS HEALTH CARE, INC. THUNGER TIGER CORP. DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER *K870027, SALTER LABS H… | 1993 |
| * | K870027 | Hand Held Pheumatic Powered (Disposable) NebulizerSummary page 1…OAF Review Panel: Anesthesiology Predicate Device: K931015, DEVILBISS HEALTH CARE, INC. THUNGER TIGER CORP. DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER *K870027, SALTER LABS HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER * K052438, EMG Technology Co., Ltd… | 1987 |
| * | K052438 | Emg Handle Nebulizer NB02 SeriesSummary page 2…HUNGER TIGER CORP. DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER *K870027, SALTER LABS HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER * K052438, EMG Technology Co., Ltd EMG Handle Nebulizer NBO2 Series Device Description: Our Quality Life Technologies Compressor Ne… | 2006 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K931015.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patients respiratory tract for the treatment of respiratory disorders. The target population for this device consists…
Read the full statement (128 words)
The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patients respiratory tract for the treatment of respiratory disorders.
The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional applications for aerosolized medication are constantly under investigation and this device may be deemed suitable for such applications as prescribed.
The intended environment for use of the product is in the patient's home on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112824: Quality Life Technologies Compressor Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112824
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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