# K012003: DRG Reaction Chamber/Safety Tip

- Pathway: 510(k) (Traditional)
- Applicant: Doctor'S Research Group, Inc.
- Decided: Feb 12, 2002 after 230 days
- Product code: HEI (Monitor, Heart-Valve Movement, Fetal, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 884.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001936 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001936: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Corp. (2000) Summary page 2.

## Indications for use
The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.

Source page: https://510kreport.com/device/K012003
Methodology: https://510kreport.com/methodology