510(k) · Cleared
Recalled · 2008Electrosurgical Cutting and Coagulation Accessories, Electrosurgical Wands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Instruments Technology, Inc. · HRX Arthroscope
Cleared on Feb 28, 2002 as substantially equivalent to K974022 (Mitek Products, 1998) and 1 other predicate after a 199-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Feb 28, 2002
- Review
- 199 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943450 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 1 generation backK962321 Arthocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1996
- This deviceK012640 Electrosurgical Cutting and Coagulation Accessories, Electrosurgical…Medical Instruments Technology, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −1 | K962321 | Arthocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1996 | — |
| 0 (this device) | K012640 | Electrosurgical Cutting and Coagulation Accessories, Electrosurgical Wands | Medical Instruments Technology, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K974022 | VAPRSummary page 1…ssification: Class Il per 21 CFR 878.4400 Predicate Device MIT’s reprocessed electrosurgical cutting and coagulation accessories are substantially equivalent to: Mitek (K974022) or Arthrocare Wands (K962321) Description of Device The cutting and coagulation system consists of a system controller that is… | 1998 |
| * | K962321 | Arthocare Arthroscopic Electrosurgery System Model 970Summary page 1…FR 878.4400 Predicate Device MIT’s reprocessed electrosurgical cutting and coagulation accessories are substantially equivalent to: Mitek (K974022) or Arthrocare Wands (K962321) Description of Device The cutting and coagulation system consists of a system controller that is connected to a power source. T… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2008 | Not classified | Z-1680-2008 | Process control | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- 6 other devices also cite its predicate K974022.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
MIT’s unique reprocessing of the wands does not change their intended use.
The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders.
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/K012640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012640: Electrosurgical Cutting and Coagulation Accessories, Electrosurgical Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012640
Report an extraction error
Are you the manufacturer?
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