510(k) · Cleared
ClearedSoftech Plus ETC02 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 Jun 4, 2014 as substantially equivalent to K961150 (Hudson Respiratory Care, Inc., 1996) after a 258-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Jun 4, 2014
- Review
- 258 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863883 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK863883 Models 4002/4102/4202 Oxy. Delivery/CO2 CannulaSalter Labs · 1986
- 1 generation backK961150 Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 1996
- This deviceK132946 Softech Plus ETC02 CannulaTeleflexmedical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK143469 SOFTECH Plus ETCO2 CannulaTeleflexmedical, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143469SOFTECH Plus ETCO2 CannulaTeleflexmedical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K132946 | Softech Plus ETC02 Cannula | Teleflexmedical, Inc. | 2014 | — |
| +1 | K143469 | SOFTECH Plus ETCO2 Cannula | Teleflexmedical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K961150 | Dual Lumen Oxygen Delivery Gas Sampling CannulaSummary page 1…Device This submission demonstrates substantial equivalence to the predicate device Double Lumen Oxygen Delivery Gas Sampling Nasal Cannula, Hudson RCI Bi-Flo - K961 150. F. Device Description The SOFTECH Plus ETC0 2 Cannula is a non-sterile disposable, single patient use device that acts a… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143469 | SOFTECH Plus ETCO2 Cannula | 2015 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K143469 (Teleflexmedical, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K961150.
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. 2014, 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 SOFTECHO 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.
Patient Population: Infant, Pediatric, Adult
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132946 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132946: Softech Plus ETC02 Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132946
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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