510(k) · Cleared
ClearedSimplygo Portable Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · CAW Generator, Oxygen, Portable
Cleared on Nov 4, 2011 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Nov 4, 2011
- Review
- 126 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK111885 Simplygo Portable Oxygen ConcentratorRespironics, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK190304 Kingon P2 Oxygen ConcentratorQingdao Kingon Medical Science and Technology Co. · 2020
- Descendant · 2 generations on · 1 of its ownK242718 Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK252268 V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK192693 Nuvo Nano Portable Oxygen ConcentratorNidek Medical Products, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K190304Kingon P2 Oxygen ConcentratorQingdao Kingon Medical Science and Technology Co. · 2020 · cites it directly2descendants
- K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025 · 3 generations on0descendants
- K192693Nuvo Nano Portable Oxygen ConcentratorNidek Medical Products, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111885 | Simplygo Portable Oxygen Concentrator | Respironics, Inc. | 2011 | — |
| +1 | K190304 | Kingon P2 Oxygen Concentrator | Qingdao Kingon Medical Science and Technology Co. | 2020 | — |
| +2 | K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025 | — |
| +3 | K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025 | — |
| +1 | K192693 | Nuvo Nano Portable Oxygen Concentrator | Nidek Medical Products, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K190304 (Qingdao Kingon Medical Science and Technology Co., 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Respironics SimplyGo Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel /mobile environments.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111885: Simplygo Portable Oxygen Concentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111885
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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