# K031485: Rinspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Kerberos Proximal Solutions
- Decided: Sep 25, 2003 after 136 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904788 (1990). 6 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974067: Fountain Infusion  Catheter  and Occluding Guide Wire, Merit Medical Systems, Inc. (1998) Summary page 1.
- K981417: Squirt Fluid Delivery System, Merit Medical Systems, Inc. (1998) Summary page 1.
- K873004: Guiding Catheter, Mallinckrodt Critical Care (1987) Summary page 1.
- K003288: Origen Dual Lumen Catheter, Origen Biomedical, Inc. (2001) Summary page 1.

## Most influential descendants
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own
- K041291: Rinspiration System (2004), 17 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own
- K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 (2006), 9 descendants of its own
- K080901: Lbi Embolectomy System (2008), 6 descendants of its own

## Indications for use
The KPS Rinspira'tionTM System is intended to infuse and aspirate in the peripheral vasculature.

Source page: https://510kreport.com/device/K031485
Methodology: https://510kreport.com/methodology