510(k) · Cleared
ClearedRollins 7 Oxygen Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rollins Medical Solutions, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 9, 2013 as substantially equivalent to K080230 (Teleflexmedical, Inc., 2008) after a 237-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Oct 9, 2013
- Review
- 237 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980407 (1998). 4 ancestors in all, the oldest K930525 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK980407 Hope NebulizerB&B Medical Technologies, Inc. · 1998
- 2 generations backK040718 TRUSTDhd Healthcare Corp. · 2004
- 1 generation backK080230 Neb-U-Mask System, Models 1895, 1896Teleflexmedical, Inc. · 2008
- This deviceK130379 Rollins 7 Oxygen MaskRollins Medical Solutions, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980407 | Hope Nebulizer | B&B Medical Technologies, Inc. | 1998 | — |
| −2 | K040718 | TRUST | Dhd Healthcare Corp. | 2004 | — |
| −1 | K080230 | Neb-U-Mask System, Models 1895, 1896 | Teleflexmedical, Inc. | 2008 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K080230 | Neb-U-Mask System, Models 1895, 1896Summary page 1…edicate Device ws9syanuactuter> Brand Name . twz51k)Nmes Teleflex Medical, Inc. Neb-U-Maske K080230 Device Description The Rollins 7 Oxygen Mask consists of the following features: 1) mask, 2) strap holes, 3) swivel, 4)… | 2008 |
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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a 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. 2013, 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 Rollins7 Oxygen Mask is placed over the nose and mouth to administer oxygen and
aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130379: Rollins 7 Oxygen Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130379
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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