# K780871: Arterial Line Kit

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Corp.
- Decided: Jun 14, 1978 after 15 days
- Product code: GDY (Gauze/Sponge, Internal, X-Ray Detectable)
- Device class: 1
- Regulation: 21 CFR 878.4450
- Recalls of this device: 11 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Jun 1, 2026 · Class I · Z-2708-2026: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Jan 24, 2022 · Class II · Z-0563-2022: Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
- Apr 8, 2020 · Class II · Z-1937-2020: Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to 
- Apr 8, 2020 · Class II · Z-1936-2020: Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to 
- Mar 29, 2010 · Not classified · Z-1741-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o
- Mar 29, 2010 · Not classified · Z-1745-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o
- Mar 29, 2010 · Not classified · Z-1744-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o
- Mar 29, 2010 · Not classified · Z-1740-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o
- Mar 29, 2010 · Not classified · Z-1737-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o
- Mar 29, 2010 · Not classified · Z-1743-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o
- Mar 29, 2010 · Not classified · Z-1742-2010: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility o

Source page: https://510kreport.com/device/K780871
Methodology: https://510kreport.com/methodology