510(k) · Cleared

Cleared

Dual Lumen Oxygen Delivery Gas Sampling Cannula

K961150510(k) TraditionalCleared Sep 10, 1996172-day reviewClass II21 CFR 868.1400

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

Hudson Respiratory Care, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Sep 10, 1996 as substantially equivalent to K892406 (Salter Labs, 1989) and 1 other predicate after a 172-day review. Its family tree reaches back 1 generation to 1986. 7 later devices descend from it.

Decided: Sep 10, 1996
Review: 172 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K863883 (1986). 2 ancestors in all. 7 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK863883 Models 4002/4102/4202 Oxy. Delivery/CO2 CannulaSalter Labs · 1986
This deviceK961150 Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 1996
Descendant · cites it directly · 2 of its ownK123176 Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013
Descendant · cites it directly · 1 of its ownK132946 Softech Plus ETC02 CannulaTeleflexmedical, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK132729 Iso-Gard MaskTeleflexmedical, Inc. · 2014
Descendant · cites it directly · 0 of its ownK161250 OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK143469 SOFTECH Plus ETCO2 CannulaTeleflexmedical, Inc. · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013high 4 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · See all

K123176Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013 · cites it directly2descendants
K132946Softech Plus ETC02 CannulaTeleflexmedical, Inc. · 2014 · cites it directly1descendant
K132729Iso-Gard MaskTeleflexmedical, Inc. · 2014 · 2 generations on1descendant
K161250OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, Inc. · 2017 · cites it directly0descendants
K143469SOFTECH Plus ETCO2 CannulaTeleflexmedical, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863883	Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula	Salter Labs	1986	—
0 (this device)	K961150	Dual Lumen Oxygen Delivery Gas Sampling Cannula	Hudson Respiratory Care, Inc.	1996	—
+1	K123176	Iso-Gard Clearair Mask	Teleflexmedical, Inc.	2013	—
+1	K132946	Softech Plus ETC02 Cannula	Teleflexmedical, Inc.	2014	—
+2	K132729	Iso-Gard Mask	Teleflexmedical, Inc.	2014	—
+1	K161250	OC-FLEX Flexible IntraOral Cannula	Venture Therapeutics, Inc.	2017	—
+2	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
2013	1	0
2014	4	0
2015	1	0
2017	1	0

FIG. 1 — Lineage of K961150, 1986–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K892406	Modified Oxygen Delivery/CO2 Sample Nasal Cannula Summary page 1 …, Oxygen Nasal Cannula Common/Usual Name: Cannula Intended Device: CO, , Oxygen Nasal Cannula Predicate Device: SALTER LABS Oxygen Delivery - CO, Sampling Nasal Cannula K 892406 and K 863883 Device Description The Hudson RCI nasal cannula with gas sampling port has bifurcated nares that channel oxygen de…	Salter Labs	1989	3
*	K863883	Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula Summary page 1 …l Cannula Common/Usual Name: Cannula Intended Device: CO, , Oxygen Nasal Cannula Predicate Device: SALTER LABS Oxygen Delivery - CO, Sampling Nasal Cannula K 892406 and K 863883 Device Description The Hudson RCI nasal cannula with gas sampling port has bifurcated nares that channel oxygen delivery throug…	Salter Labs	1986	—

Also cleared against K892406: 3 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K123176	Iso-Gard Clearair Mask	Teleflexmedical, Inc.	2013	2
K132946	Softech Plus ETC02 Cannula	Teleflexmedical, Inc.	2014	1
K161250	OC-FLEX Flexible IntraOral Cannula	Venture Therapeutics, Inc.	2017	0
K131410	CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal Cannula (with 8…	Southmedic, Inc.	2014	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K123176 (Teleflexmedical, Inc., 2013) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K892406.

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

2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007high 592 (2024) · low 56 (2007)2026

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

Recalls per year · CCK

1in 2022

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

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

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 Gas Sampling Oxygen 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K961150 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961150: Dual Lumen Oxygen Delivery Gas Sampling Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961150

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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