# K952516: Pro-Vent, Line Draw, Pulsator

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: Jul 14, 1995 after 44 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K981035: Pro-Vent, Pulsator Arterial Blood Sampling Syringes (1998), 0 descendants of its own

## Recalls of this device
- Dec 19, 2025 · Class II · Z-1100-2026: Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial
- Sep 6, 2023 · Class II · Z-0141-2024: The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31
- Jan 7, 2020 · Class II · Z-1715-2020: Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
- Jan 7, 2020 · Class II · Z-1716-2020: Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
- Jun 22, 2018 · Class II · Z-0843-2019: The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
- Jun 22, 2018 · Class II · Z-0842-2019: The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
- Dec 17, 2014 · Class III · Z-1028-2015: The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
- Nov 22, 2013 · Class II · Z-1187-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1181-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1190-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1186-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1184-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1183-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1188-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1191-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1189-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1182-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1180-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1192-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Nov 22, 2013 · Class II · Z-1185-2014: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
- Sep 9, 2004 · Not classified · Z-0244-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0248-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0249-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0250-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0251-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0254-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0227-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0246-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0247-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0252-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0253-05: Sterility of the device is compromised due to packaging defects

Source page: https://510kreport.com/device/K952516
Methodology: https://510kreport.com/methodology