510(k) · Cleared
ClearedModels 4002/4102/4202 Oxy. Delivery/CO2 Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Oct 27, 1986 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Oct 27, 1986
- Review
- 21 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK863883 Models 4002/4102/4202 Oxy. Delivery/CO2 CannulaSalter Labs · 1986
- Descendant · cites it directly · 7 of its ownK961150 Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK151421 Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2…Salter Labs · 2016
- Descendant · 2 generations on · 2 of its ownK123176 Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK181981 CO2 Sampling LineTylenol Medical Instruments Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK132946 Softech Plus ETC02 CannulaTeleflexmedical, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K961150Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 1996 · cites it directly7descendants
- K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula…Salter Labs · 2016 · cites it directly2descendants
- K123176Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013 · 2 generations on2descendants
- K181981CO2 Sampling LineTylenol Medical Instruments Co., Ltd. · 2019 · 2 generations on1descendant
- K132946Softech Plus ETC02 CannulaTeleflexmedical, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863883 | Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula | Salter Labs | 1986 | — |
| +1 | K961150 | Dual Lumen Oxygen Delivery Gas Sampling Cannula | Hudson Respiratory Care, Inc. | 1996 | — |
| +1 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2… | Salter Labs | 2016 | — |
| +2 | K123176 | Iso-Gard Clearair Mask | Teleflexmedical, Inc. | 2013 | — |
| +2 | K181981 | CO2 Sampling Line | Tylenol Medical Instruments Co., Ltd. | 2019 | — |
| +2 | K132946 | Softech Plus ETC02 Cannula | Teleflexmedical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 123 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, K961150 (Hudson Respiratory Care, Inc., 1996) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K863883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K863883: Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863883
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026