# K151421: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Mar 10, 2016 after 287 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863703 (1986). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863703: Salter Labs Model 4000 Nasal CO2 Sample Line, Salter Labs (1986) Summary page 5.
- K863883: Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula, Salter Labs (1986) Summary page 5.
- K864199: Salter Labs #4001 Oral Nasal CO2 Sampling Cannula, Salter Labs (1987) Summary page 5.
- K864902: Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu., Salter Labs (1987) Summary page 5.
- K892406: Modified Oxygen Delivery/CO2 Sample Nasal Cannula, Salter Labs (1989) Summary page 5.
- K894350: Salter Labs Model #4009 Sample Lines, Salter Labs (1989) Summary page 5.

## Most influential descendants
- K181981: CO2 Sampling Line (2019), 1 descendant of its own
- K251216: 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K151421
Methodology: https://510kreport.com/methodology