510(k) · Cleared
ClearedAutoneb Breath Actuated Controller and Accessory Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vortran Medical Technology 1, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 25, 1994 after a 269-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Aug 25, 1994
- Review
- 269 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 5 citing it directly.
- This deviceK935693 Autoneb Breath Actuated Controller and Accessory KitVortran Medical Technology 1, Inc. · 1994
- Descendant · cites it directly · 12 of its ownK981772 Halolite Aad SystemMedic-Aid, Ltd. · 1998
- Descendant · 2 generations on · 11 of its ownK991685 Halolite Aad System with Dedicated CompressorMedic-Aid, Ltd. · 1999
- Descendant · cites it directly · 10 of its ownK030747 Prodose Aad SystemProfile Therapeutics Plc · 2004
- Descendant · 2 generations on · 6 of its ownK042991 I-Neb Aad SystemProfile Therapeutics Plc · 2005
- Descendant · 3 generations on · 4 of its ownK100380 Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K981772Halolite Aad SystemMedic-Aid, Ltd. · 1998 · cites it directly12descendants
- K991685Halolite Aad System with Dedicated CompressorMedic-Aid, Ltd. · 1999 · 2 generations on11descendants
- K030747Prodose Aad SystemProfile Therapeutics Plc · 2004 · cites it directly10descendants
- K042991I-Neb Aad SystemProfile Therapeutics Plc · 2005 · 2 generations on6descendants
- K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935693 | Autoneb Breath Actuated Controller and Accessory Kit | Vortran Medical Technology 1, Inc. | 1994 | — |
| +1 | K981772 | Halolite Aad System | Medic-Aid, Ltd. | 1998 | — |
| +2 | K991685 | Halolite Aad System with Dedicated Compressor | Medic-Aid, Ltd. | 1999 | — |
| +1 | K030747 | Prodose Aad System | Profile Therapeutics Plc | 2004 | — |
| +2 | K042991 | I-Neb Aad System | Profile Therapeutics Plc | 2005 | — |
| +3 | K100380 | Altera Nebulizer System, Model 678G1002 | Pari Respiratory Equipment, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 135 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, K981772 (Medic-Aid, Ltd., 1998) has gone furthest, with 12 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 | — |
https://510kreport.com/device/K935693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K935693: Autoneb Breath Actuated Controller and Accessory Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935693
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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