510(k) · Cleared
ClearedDRG Reaction Chamber/Safety Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doctor'S Research Group, Inc. · HEI Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Cleared on Feb 12, 2002 as substantially equivalent to K001936 (Arthrocare Corp., 2000) after a 230-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 12, 2002
- Review
- 230 days
- Class
- Class II
- Product code
- HEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001936 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001936 Arthrocare Controller, Arthrocare Cable, Footswitch, PowercordArthrocare Corp. · 2000
- This deviceK012003 DRG Reaction Chamber/Safety TipDoctor'S Research Group, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001936 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord | Arthrocare Corp. | 2000 | — |
| 0 (this device) | K012003 | DRG Reaction Chamber/Safety Tip | Doctor'S Research Group, Inc. | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001936 | Arthrocare Controller, Arthrocare Cable, Footswitch, PowercordSummary page 2…ArthroCare Electrosurgery Systems (ENTec® Surgery System with ENTec™ Plasma Scalpel™, ArthroCare® Orthopedic Electrosurgery System, ArthroCare® Electrosurgery System) (K001936) Device Description The DRG Reaction Chamber/Safety Tip is an accessory for Coblation® electrosurgical devices. It creates a se… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K001936.
How does its category compare?
All HEI devicesHEI Monitor, Heart-Valve Movement, Fetal, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEI
FDA has decided no HEI device since 2007.
Median 510(k) review, days · HEI
Too few HEI 510(k)s in any year since 2007 to give a median.
Recalls per year · HEI
No recall names HEI since 2007.
Adverse event reports per year · HEI
1in 2012
MAUDE reports naming product code HEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012003: DRG Reaction Chamber/Safety Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012003
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026