510(k) · Cleared

Cleared

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

K151421510(k) TraditionalCleared Mar 10, 2016287-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

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

Cleared on Mar 10, 2016 as substantially equivalent to K863703 (Salter Labs, 1986) and 5 other predicates after a 287-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.

Decided: Mar 10, 2016
Review: 287 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K863703 (1986). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK863703 Salter Labs Model 4000 Nasal CO2 Sample LineSalter Labs · 1986
This deviceK151421 Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2…Salter Labs · 2016
Descendant · cites it directly · 1 of its ownK181981 CO2 Sampling LineTylenol Medical Instruments Co., Ltd. · 2019
Descendant · 2 generations on · 0 of its ownK251216 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling…Barbaras Development, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all

K181981CO2 Sampling LineTylenol Medical Instruments Co., Ltd. · 2019 · cites it directly1descendant
K2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…Barbaras Development, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863703	Salter Labs Model 4000 Nasal CO2 Sample Line	Salter Labs	1986	—
0 (this device)	K151421	Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2…	Salter Labs	2016	—
+1	K181981	CO2 Sampling Line	Tylenol Medical Instruments Co., Ltd.	2019	—
+2	K251216	0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182…	Barbaras Development, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	2	0
1989	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2025	1	0

FIG. 1 — Lineage of K151421, 1986–2025Source: 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? (6)

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
*	K863703	Salter Labs Model 4000 Nasal CO2 Sample Line Summary page 5 …Sample Lines Predicate Devices: This submission demonstrates substantial equivalence to the predicate devices: K863703, Nasal CO2 Sample Line K863883, O2 Delivery / CO2 Sampling Nasal Cannula K864199, Oral / Nasal CO2 Sampling Cannula…	Salter Labs	1986	—
*	K863883	Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula Summary page 5 …es Predicate Devices: This submission demonstrates substantial equivalence to the predicate devices: K863703, Nasal CO2 Sample Line K863883, O2 Delivery / CO2 Sampling Nasal Cannula K864199, Oral / Nasal CO2 Sampling Cannula K864902, O2 Delivery with Oral…	Salter Labs	1986	—
*	K864199	Salter Labs #4001 Oral Nasal CO2 Sampling Cannula Summary page 5 …sion demonstrates substantial equivalence to the predicate devices: K863703, Nasal CO2 Sample Line K863883, O2 Delivery / CO2 Sampling Nasal Cannula K864199, Oral / Nasal CO2 Sampling Cannula K864902, O2 Delivery with Oral / Nasal CO2 Sampling Cannula K892406, Divided O2…	Salter Labs	1987	—
*	K864902	Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu. Summary page 5 …redicate devices: K863703, Nasal CO2 Sample Line K863883, O2 Delivery / CO2 Sampling Nasal Cannula K864199, Oral / Nasal CO2 Sampling Cannula K864902, O2 Delivery with Oral / Nasal CO2 Sampling Cannula K892406, Divided O2 Delivery / CO2 Sampling Nasal Cannula K8943…	Salter Labs	1987	—
*	K892406	Modified Oxygen Delivery/CO2 Sample Nasal Cannula Summary page 5 …883, O2 Delivery / CO2 Sampling Nasal Cannula K864199, Oral / Nasal CO2 Sampling Cannula K864902, O2 Delivery with Oral / Nasal CO2 Sampling Cannula K892406, Divided O2 Delivery / CO2 Sampling Nasal Cannula K894350, Sample Lines The proposed devices that correspond to the…	Salter Labs	1989	3
*	K894350	Salter Labs Model #4009 Sample Lines Summary page 5 …l / Nasal CO2 Sampling Cannula K864902, O2 Delivery with Oral / Nasal CO2 Sampling Cannula K892406, Divided O2 Delivery / CO2 Sampling Nasal Cannula K894350, Sample Lines The proposed devices that correspond to these predicates have identical names and are listed in the t…	Salter Labs	1989	1

Also cleared against K863703: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181981	CO2 Sampling Line	Tylenol Medical Instruments Co., Ltd.	2019	1

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?

2 of the 6 ancestors have a recall of any class.
Of its descendants, K181981 (Tylenol Medical Instruments Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K863703.

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. 2016, this device’s year, is highlighted.

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 Nasal CO2 Sample Line is intended to be used to sample exhaled gas. The O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored. The Oral / Nasal CO2 Sampling Cannula is intended to be used where exhaled gas is monitored. The O2 Delivery with Oral / Nasal CO2 Sampling Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored. The Divided…

Read the full statement (144 words)

The Nasal CO2 Sample Line is intended to be used to sample exhaled gas.

The O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Oral / Nasal CO2 Sampling Cannula is intended to be used where exhaled gas is monitored.

The O2 Delivery with Oral / Nasal CO2 Sampling Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Divided O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Sample Lines are intended to be used where exhaled gas is monitored.

Environment of use – hospital, sub-acute, and pre-hospital settings.

Patient population – Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151421 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151421: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151421

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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