510(k) · Cleared
Recalled · Class II · 2017Oxyarm CO2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southmedic, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Jun 11, 2002 as substantially equivalent to K971229 (Medsys, Inc., 1997) and 1 other predicate after a 172-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.
- Decided
- Jun 11, 2002
- Review
- 172 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K942907 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK942907 Jemsdal MaskRespan Products, Inc. · 1994
- This deviceK014211 Oxyarm CO2Southmedic, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942907 | Jemsdal Mask | Respan Products, Inc. | 1994 | — |
| 0 (this device) | K014211 | Oxyarm CO2 | Southmedic, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 CCK? 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971229 | Capnoxygen MaskSummary page 1…s phase Device: Oxygen I Carbon Dioxide Sampling Mask Predicate Devices: Medsys I Southmedic - Capnoxygen mask - K97 1229 Southmedic - OxyArm oxygen - KO0 1865 Respan Ox… | 1997 |
| Kept off the family tree | K001865 | Southmedic - OxyArm oxygen Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K942907 | Jemsdal MaskSummary page 1…- Capnoxygen mask - K97 1229 Southmedic - OxyArm oxygen - KO0 1865 Respan Oxygen mask - K942907 The Southmedic OxyArm C02 is an oxygen delivery device with a headset and oxygen delivery port, which is placed in front of t… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2017 | Class II | Z-1288-2018 | Device Design | Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K971229.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
To deliver oxygen to patients in low to medium concentrations and provides a means to sample expired gases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014211: Oxyarm CO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014211
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026