# K894350: Salter Labs Model #4009 Sample Lines

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Oct 3, 1989 after 81 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K151421: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines (2016), 2 descendants of its own
- 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

## Recalls of this device
- Nov 1, 2013 · Class II · Z-0360-2014: It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.

Source page: https://510kreport.com/device/K894350
Methodology: https://510kreport.com/methodology