510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Modified Oxygen Delivery/CO2 Sample Nasal Cannula

K892406510(k) TraditionalCleared Jul 24, 1989108-day reviewClass II21 CFR 868.1400Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Salter Labs · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Jul 24, 1989 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled 3 times.

Decided
Jul 24, 1989
Review
108 days
Class
Class II
Product code
CCK
Recalls
3
Predicates
0

12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2012: 1 descendant cleared2014: 4 descendants cleared1996: 1 descendant cleared2019: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK892406 Modified Oxygen Delivery/CO2 Sample Nasal CannulaSalter Labs · 1989
  2. Descendant · cites it directly · 7 of its ownK961150 Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 1996
  3. Descendant · cites it directly · 2 of its ownK151421 Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2…Salter Labs · 2016
  4. Descendant · 2 generations on · 2 of its ownK123176 Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013
  5. Descendant · 2 generations on · 1 of its ownK181981 CO2 Sampling LineTylenol Medical Instruments Co., Ltd. · 2019
  6. 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

1996: 12012: 12013: 12014: 42015: 12016: 12017: 12019: 12025: 1
1996high 4 (2014) · low 0 (1997)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K892406Modified Oxygen Delivery/CO2 Sample Nasal CannulaSalter Labs1989—
+1K961150Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc.1996—
+1K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2…Salter Labs2016—
+2K123176Iso-Gard Clearair MaskTeleflexmedical, Inc.2013—
+2K181981CO2 Sampling LineTylenol Medical Instruments Co., Ltd.2019—
+2K132946Softech Plus ETC02 CannulaTeleflexmedical, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
201210
201310
201440
201510
201610
201710
201910
202510
FIG. 1 — Lineage of K892406, 1989–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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 12

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961150Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc.19967
K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula…Salter Labs20162
K131410CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal Cannula (with 8…Southmedic, Inc.20140
K120518End Tidal CO2 Nasal CannulaCare Fusion20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 30, 2012Class IIZ-1898-2012PackagingA complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector.
Dec 7, 2011Not classifiedZ-0605-2012Process controlMis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).
Apr 19, 2011Not classifiedZ-2237-2011Labeling mix-upsComplaint received that the product in the box was different from labeled product.

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 devices

CCK 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

2007: 52008: 32009: 32010: 32011: 22012: 72013: 42014: 92015: 52016: 22017: 52018: 62019: 72020: 42021: 42022: 32023: 42024: 32025: 32026 (partial year): 3
2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007: 56 days median2008: 248 days median2009: 101 days median2010: 125 days median2012: 150 days median2013: 132 days median2014: 166 days median2015: 105 days median2017: 134 days median2018: 296 days median2019: 261 days median2020: 188 days median2021: 227 days median2022: 226 days median2023: 555 days median2024: 592 days median2025: 169 days median2026 (partial year): 224 days median
2007high 592 (2024) · low 56 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CCK

1in 2022

2008: 12009: 192010: 42011: 142012: 32013: 2, 1 Class I2015: 12018: 52019: 7, 7 Class I2020: 12022: 1
2007high 19 (2009) · low 0 (2007)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · CCK

1,259in 2025

2007: 72008: 202009: 212010: 122011: 182012: 132013: 282014: 512015: 1142016: 882017: 582018: 632019: 1412020: 2,3022021: 2,2722022: 2,4752023: 1,6372024: 1,2162025: 1,259
2007high 2,475 (2022) · low 7 (2007)2025

MAUDE reports naming product code CCK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200755607
20083248120
200931011921
20103125412
20112—1418
20127150313
201341322 (1)28
20149166051
201551051114
20162—088
20175134058
20186296563
201972617 (7)141
2020418812,302
2021422702,272
2022322612,475
2023455501,637
2024359201,216
2025316901,259
202632240—

More from Salter Labs

49 FDA decisions under this applicant name. See the company

  • K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026
  • K161719Salter Labs Bubble HumidifierSalter Labs · 2017
  • K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow…Salter Labs · 2016
  • K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs · 2016
  • K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs · 2016

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The CCK category page

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https://510kreport.com/device/K892406 · printed Nov 4, 2026

Cite this page

510(k) Report. “K892406: Modified Oxygen Delivery/CO2 Sample Nasal Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K892406

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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