510(k) · Cleared
ClearedNeb-U-Mask System, Models 1895, 1896
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 9, 2008 as substantially equivalent to K980407 (B&B Medical Technologies, Inc., 1998) and 2 other predicates after a 131-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Jun 9, 2008
- Review
- 131 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K980407 (1998). 3 ancestors in all, the oldest K930525 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980407 Hope NebulizerB&B Medical Technologies, Inc. · 1998
- 1 generation backK040718 TRUSTDhd Healthcare Corp. · 2004
- This deviceK080230 Neb-U-Mask System, Models 1895, 1896Teleflexmedical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK130379 Rollins 7 Oxygen MaskRollins Medical Solutions, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130379Rollins 7 Oxygen MaskRollins Medical Solutions, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980407 | Hope Nebulizer | B&B Medical Technologies, Inc. | 1998 | — |
| −1 | K040718 | TRUST | Dhd Healthcare Corp. | 2004 | — |
| 0 (this device) | K080230 | Neb-U-Mask System, Models 1895, 1896 | Teleflexmedical, Inc. | 2008 | — |
| +1 | K130379 | Rollins 7 Oxygen Mask | Rollins Medical Solutions, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K980407 | Hope NebulizerSummary page 1…(direct patient interference) CAF - 868.5630 Predicate Devices: B&B Technology - Hope nebulizer - K980407 DHD Healthcare - Trust nebulizer - K040718… | 1998 |
| * | K040718 | TRUSTSummary page 1…0 Predicate Devices: B&B Technology - Hope nebulizer - K980407 DHD Healthcare - Trust nebulizer - K040718 Teleflex Medical /Hudson RCI - Micro Mist Nebulizer… | 2004 |
| * | K930525 | Micro Mist (TM) NebulizerSummary page 1…Trust nebulizer - K040718 Teleflex Medical /Hudson RCI - Micro Mist Nebulizer - K930525 Device Description: The Neb-U-Mask® System is intended to be with oxygen and oxygen-helium (Heliox) mixtures that include a non-r… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130379 | Rollins 7 Oxygen Mask | 2013 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130379 (Rollins Medical Solutions, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K980407.
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?
For the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations. This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080230: Neb-U-Mask System, Models 1895, 1896.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080230
Report an extraction error
Are you the manufacturer?
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