510(k) · Cleared
ClearedInnosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC Power Supply Accessory)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sim Italia S.R.L. · CAW Generator, Oxygen, Portable
Cleared on Oct 3, 1997 as substantially equivalent to K963042 (Sim Italia S.R.L., 1996) after a 128-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 3, 1997
- Review
- 128 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933081 (1994). 4 ancestors in all, the oldest K852650 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 2 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 1 generation backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- This deviceK971947 Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO.…Sim Italia S.R.L. · 1997
- Descendant · cites it directly · 0 of its ownK053230 Merits Health Products Oxygen ConcentratorsMerits Health Products Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK030233 Travelsome StandardSim Italia S.R.L. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −2 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −1 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| 0 (this device) | K971947 | Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853… | Sim Italia S.R.L. | 1997 | — |
| +1 | K053230 | Merits Health Products Oxygen Concentrators | Merits Health Products Co., Ltd. | 2006 | — |
| +1 | K030233 | Travelsome Standard | Sim Italia S.R.L. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 CAW? 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 CAW device
- #1 K230052 Inogen Rove 6score 29.9 · 2 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 |
|---|---|---|---|
| * | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Summary page 1…Innosan Travelair® "S" Plus Portable Oxygen Concentrator 3. Predicate Device Information: Innosan Travelair® “S” Portable Oxygen Concentrator, Code No. M407001853, K#963042. 4. Device Description: The Innosan Travelair® “S” Plus Portable Oxygen Concentrator is a mobile oxygen concentrator intended f… | 1996 |
What descends from it? (2)
2 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 3 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K053230 (Merits Health Products Co., Ltd., 2006) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K963042.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAW
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAW
611in 2025
MAUDE reports naming product code CAW, 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 | 6 | 143 | 1 | 23 |
| 2008 | 11 | 90 | 3 | 25 |
| 2009 | 8 | 193 | 2 | 43 |
| 2010 | 5 | 133 | 0 | 48 |
| 2011 | 6 | 174 | 1 | 167 |
| 2012 | 5 | 148 | 0 | 395 |
| 2013 | 2 | — | 2 | 2,309 |
| 2014 | 6 | 277 | 2 | 24,538 |
| 2015 | 1 | — | 0 | 18,973 |
| 2016 | 1 | — | 1 | 3,167 |
| 2017 | 1 | — | 1 | 107 |
| 2018 | 3 | 203 | 0 | 116 |
| 2019 | 2 | — | 2 | 120 |
| 2020 | 5 | 224 | 1 | 125 |
| 2021 | 2 | — | 0 | 194 |
| 2022 | 4 | 458 | 2 | 305 |
| 2023 | 8 | 261 | 0 | 357 |
| 2024 | 2 | — | 5 (1) | 450 |
| 2025 | 12 | 178 | 1 | 611 |
| 2026 | 6 | 260 | 0 | — |
What is it indicated for?
The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile’s battery or for use with a power supply accessory (off of a mains current - 110 VAC, 60 Hz or 220 VAC, 50 Hz) when the patient is away from their primary home oxygen source, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.
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/K971947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971947: Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC Power Supply Accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971947
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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