# K780551: I.V. Administration Set with Mini-Spike

- Pathway: 510(k) (Traditional)
- Applicant: National Patent Development Corp.
- Decided: Apr 19, 1978 after 14 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
71 later devices descend from it; 1 cites it directly.
4 of 72 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
- K040013: Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit (2004), 70 descendants of its own
- K052256: Angiojet Xpeedior 120 Catheter (2005), 68 descendants of its own
- K061951: Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 (2006), 66 descendants of its own
- K071514: Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 (2007), 63 descendants of its own
- K071342: Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039 (2007), 34 descendants of its own

## Recalls of this device
- Sep 26, 2023 · Class II · Z-0128-2024: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to ha
- Sep 26, 2023 · Class II · Z-0129-2024: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to ha

Source page: https://510kreport.com/device/K780551
Methodology: https://510kreport.com/methodology