510(k) · Cleared
ClearedSingle Use Arthroscopic Electrode (with Pencil)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modern Medical Equipment Manufacturing Limited · HRX Arthroscope
Cleared on May 31, 2018 as substantially equivalent to K020579 (Aaron Medical Industries, 2002) after a 449-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- May 31, 2018
- Review
- 449 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945030 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK945030 Surgi-Link Laparoscopic ElectrodesUnimed Surgical Products, Inc. · 1994
- 2 generations backK970066 Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation ElectrodeUnimed Surgical Products, Inc. · 1997 · Recalled
- 1 generation backK020579 Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and…Aaron Medical Industries · 2002
- This deviceK170703 Single Use Arthroscopic Electrode (with Pencil)Modern Medical Equipment Manufacturing Limited · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945030 | Surgi-Link Laparoscopic Electrodes | Unimed Surgical Products, Inc. | 1994 | — |
| −2 | K970066 | Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode | Unimed Surgical Products, Inc. | 1997 | 1 |
| −1 | K020579 | Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03 | Aaron Medical Industries | 2002 | — |
| 0 (this device) | K170703 | Single Use Arthroscopic Electrode (with Pencil) | Modern Medical Equipment Manufacturing Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 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? (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 |
|---|---|---|---|
| * | K020579 | Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03Summary page 4…& Plastic Surgery Product Code: HRX, GEI Class: II 3. Predicate device Aaron Arthroscopy Electrodes with 510(k) number K020579. 4. Device description Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode… | 2002 |
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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170703: Single Use Arthroscopic Electrode (with Pencil).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170703
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026