# K001251: Sniper, Model or-3872XX Series

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Jul 7, 2000 after 79 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 5 (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
- K060034: Nipro Hydrophilic Guidewire for Urological & Laparoscopic Use (2006), 0 descendants of its own

## Recalls of this device
- Jul 27, 2012 · Class II · Z-0136-2013: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctio
- Jul 27, 2012 · Class II · Z-0138-2013: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctio
- Jul 27, 2012 · Class II · Z-0134-2013: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctio
- Jul 27, 2012 · Class II · Z-0135-2013: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctio
- Jul 27, 2012 · Class II · Z-0137-2013: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctio

Source page: https://510kreport.com/device/K001251
Methodology: https://510kreport.com/methodology