510(k) · Cleared
ClearedSOFTECH Plus ETCO2 Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 12, 2015 as substantially equivalent to K132946 (Teleflexmedical, Inc., 2014) after a 69-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Feb 12, 2015
- Review
- 69 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K863883 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK863883 Models 4002/4102/4202 Oxy. Delivery/CO2 CannulaSalter Labs · 1986
- 2 generations backK961150 Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 1996
- 1 generation backK132946 Softech Plus ETC02 CannulaTeleflexmedical, Inc. · 2014
- This deviceK143469 SOFTECH Plus ETCO2 CannulaTeleflexmedical, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863883 | Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula | Salter Labs | 1986 | — |
| −2 | K961150 | Dual Lumen Oxygen Delivery Gas Sampling Cannula | Hudson Respiratory Care, Inc. | 1996 | — |
| −1 | K132946 | Softech Plus ETC02 Cannula | Teleflexmedical, Inc. | 2014 | — |
| 0 (this device) | K143469 | SOFTECH Plus ETCO2 Cannula | Teleflexmedical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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? (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 |
|---|---|---|---|
| * | K132946 | Softech Plus ETC02 CannulaSummary page 4…ification Panel: Anesthesiology E. Predicate Device This submission demonstrates substantial equivalence to the predicate device SOFTECH® Plus ETCO2 Cannula – K132946, with the addition of a shelf-life. F. Device Description The SOFTECH Plus ETCO2 Cannula is a non-sterile disposable, single… | 2014 |
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 29 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2015, this device’s year, is highlighted.
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?
The Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143469: SOFTECH Plus ETCO2 Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143469
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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