510(k) · Cleared
ClearedTravelsome Standard
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 Apr 25, 2003 as substantially equivalent to K971947 (Sim Italia S.R.L., 1997) and 1 other predicate after a 92-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Apr 25, 2003
- Review
- 92 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933081 (1994). 5 ancestors in all, the oldest K852650 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 3 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 2 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
- 1 generation backK971947 Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO.…Sim Italia S.R.L. · 1997
- This deviceK030233 Travelsome StandardSim Italia S.R.L. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −3 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −2 | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 | Sim Italia S.R.L. | 1996 | — |
| −1 | K971947 | Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853… | Sim Italia S.R.L. | 1997 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K971947 | Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC…Summary page 1…tor 3. Predicate Device Information: 1. lnnosan Travelaia "S" Portable Oxygen Concentrator, Model NO. M 407001853 (with AC Power Supply Accessory), K#971947, Sim ltalia S.r.l., Italy. 2. lnnosan Travelaia "S" Portable Oxygen Concentrator, K#963042, Sim M i a s.… | 1997 |
| * | K963042 | Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Summary page 1…l NO. M 407001853 (with AC Power Supply Accessory), K#971947, Sim ltalia S.r.l., Italy. 2. lnnosan Travelaia "S" Portable Oxygen Concentrator, K#963042, Sim M i a s.r,l., Italy. 4. Device Description: The TraveSome@Standard Portable Oxygen Concentrator is a mo… | 1996 |
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 9 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K971947.
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 TravelSome Standard Portable Oxygen Concentrator is intended to provide
supplemental oxygen to patients with respiratory disorders for use in the home,
or during travel by car.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030233: Travelsome Standard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030233
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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