# K905447: E-Z-EM Pulsed Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: E-Z-Em, Inc.
- Decided: Apr 1, 1991 after 117 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 4 (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
- Aug 6, 2014 · Class II · Z-2261-2014: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
- Aug 6, 2014 · Class II · Z-2260-2014: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
- Aug 6, 2014 · Class II · Z-2262-2014: AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
- May 17, 2010 · Not classified · Z-1707-2010: This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occ

Source page: https://510kreport.com/device/K905447
Methodology: https://510kreport.com/methodology