510(k) · Cleared
Recalled · 2008Reprocessed Electrosurgical Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · JOS Electrode, Electrosurgical
Cleared on Jan 18, 2002 as substantially equivalent to K000348 (Stryker Leibinger, 2000) after a 157-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Jan 18, 2002
- Review
- 157 days
- Class
- Class II
- Product code
- JOS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000348 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000348 Colorado Microdissection NeedleStryker Leibinger · 2000
- This deviceK012684 Reprocessed Electrosurgical ElectrodeSterilmed, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000348 | Colorado Microdissection Needle | Stryker Leibinger | 2000 | — |
| 0 (this device) | K012684 | Reprocessed Electrosurgical Electrode | Sterilmed, 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 JOS? 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 |
|---|---|---|---|
| * | K000348 | Colorado Microdissection NeedleSummary page 1…ocessed electrosurgical electrodes are substantially equivalent to: e The Colorado Micro-Dissection Needle manufactured by Stryker Leibinger / Colorado Biomedical Inc (K000348) e Similar devices from other manufacturers SterilMed’s reprocessed electrosurgical electrodes are a monopolar electrosurgical… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0552-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K000348.
How does its category compare?
All JOS devicesJOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JOS
Too few JOS 510(k)s in any year since 2007 to give a median.
Recalls per year · JOS
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOS
6in 2025
MAUDE reports naming product code JOS, 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 | 29 |
| 2008 | 0 | — | 1 | 37 |
| 2009 | 0 | — | 0 | 62 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 2 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 2 | 17 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing of soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.
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/K012684 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012684: Reprocessed Electrosurgical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012684
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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