510(k) · Cleared
ClearedHalolite Aad System with Dedicated Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medic-Aid, Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 13, 1999 as substantially equivalent to K981772 (Medic-Aid, Ltd., 1998) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1994. 11 later devices descend from it.
- Decided
- Aug 13, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933535 (1994). 4 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK933535 Ventstream Drug NebulizerMedic-Aid, Ltd. · 1994
- 1 generation backK981772 Halolite Aad SystemMedic-Aid, Ltd. · 1998
- This deviceK991685 Halolite Aad System with Dedicated CompressorMedic-Aid, Ltd. · 1999
- Descendant · cites it directly · 10 of its ownK030747 Prodose Aad SystemProfile Therapeutics Plc · 2004
- Descendant · cites it directly · 6 of its ownK042991 I-Neb Aad SystemProfile Therapeutics Plc · 2005
- Descendant · 2 generations on · 4 of its ownK100380 Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010
- Descendant · 3 generations on · 3 of its ownK112859 Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK072019 AKITA2 ApixnebActivaero America, Inc. · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K030747Prodose Aad SystemProfile Therapeutics Plc · 2004 · cites it directly10descendants
- K042991I-Neb Aad SystemProfile Therapeutics Plc · 2005 · cites it directly6descendants
- K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010 · 2 generations on4descendants
- K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012 · 3 generations on3descendants
- K072019AKITA2 ApixnebActivaero America, Inc. · 2007 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933535 | Ventstream Drug Nebulizer | Medic-Aid, Ltd. | 1994 | — |
| −1 | K981772 | Halolite Aad System | Medic-Aid, Ltd. | 1998 | — |
| 0 (this device) | K991685 | Halolite Aad System with Dedicated Compressor | Medic-Aid, Ltd. | 1999 | — |
| +1 | K030747 | Prodose Aad System | Profile Therapeutics Plc | 2004 | — |
| +1 | K042991 | I-Neb Aad System | Profile Therapeutics Plc | 2005 | — |
| +2 | K100380 | Altera Nebulizer System, Model 678G1002 | Pari Respiratory Equipment, Inc. | 2010 | — |
| +3 | K112859 | Erapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2012 | — |
| +2 | K072019 | AKITA2 Apixneb | Activaero America, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (2)
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 |
|---|---|---|---|
| * | K981772 | Halolite Aad SystemSummary page 1…h Dedicated Compressor System Common/Usual Name: Nebulizer Classification Name: Nebulizer, Direct Patient Interface Predicate Devices: Medic-Aid HaloLite ADD System - K981772 Invacare - Medi-Pump Mobilaire (50 psi Compressor) K950867 The Medic-Aid HaloLite AAD system with dedicated compressor is a sing… | 1998 |
| * | K950867 | Medi - PumpSummary page 1…Classification Name: Nebulizer, Direct Patient Interface Predicate Devices: Medic-Aid HaloLite ADD System - K981772 Invacare - Medi-Pump Mobilaire (50 psi Compressor) K950867 The Medic-Aid HaloLite AAD system with dedicated compressor is a single patient use, prescribed portable nebulizer designed to… | 1995 |
What descends from it? (11)
See all 112 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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030747 (Profile Therapeutics Plc, 2004) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K981772.
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?
A HaloLite Adaptive Aerosol Delivery, (AAD) system, a handheld nebulizer system including a dedicated compressor is designed to aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991685: Halolite Aad System with Dedicated Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991685
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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