# K895367: Intravenous Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Medical Product Specialists
- Decided: Oct 6, 1989 after 39 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 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
- K072783: Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed Blood Collection System with (2007), 14 descendants of its own
- K081229: Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing (2008), 13 descendants of its own
- K142946: TIVA (2015), 8 descendants of its own
- K152924: TIVA¿ (2016), 7 descendants of its own
- K163508: PIVO (2017), 6 descendants of its own

## Recalls of this device
- Jun 5, 2026 · Class II · Z-2645-2026: May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral med
- Dec 18, 2009 · Not classified · Z-1080-2010: Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
- Dec 18, 2009 · Not classified · Z-1077-2010: Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
- Dec 18, 2009 · Not classified · Z-1079-2010: Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
- Dec 18, 2009 · Not classified · Z-1076-2010: Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
- Dec 18, 2009 · Not classified · Z-1078-2010: Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.

Source page: https://510kreport.com/device/K895367
Methodology: https://510kreport.com/methodology