510(k) · Cleared
Recalled · Class II · 2012Bard Ems System 6000 E.S.U.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · HAM Apparatus, Electrosurgical
Cleared on May 11, 1987 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled once.
- Decided
- May 11, 1987
- Review
- 28 days
- Class
- Class II
- Product code
- HAM
- Recalls
- 1
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK871435 Bard Ems System 6000 E.S.U.C.R. Bard, Inc. · 1987
- Descendant · cites it directly · 17 of its ownK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
- Descendant · 2 generations on · 16 of its ownK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
- Descendant · 3 generations on · 14 of its ownK112233 Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012
- Descendant · 4 generations on · 13 of its ownK151325 Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · Recalled
- Descendant · 5 generations on · 12 of its ownK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K030819Plasmajet SystemPlasma Surgical, Ltd. · 2004 · cites it directly17descendants
- K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece…Bovie Medical · 2009 · 2 generations on16descendants
- K112233Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012 · 3 generations on14descendants
- K151325Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · 4 generations on13descendants
- K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871435 | Bard Ems System 6000 E.S.U. | C.R. Bard, Inc. | 1987 | — |
| +1 | K030819 | Plasmajet System | Plasma Surgical, Ltd. | 2004 | — |
| +2 | K090586 | Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable… | Bovie Medical | 2009 | — |
| +3 | K112233 | Bovie J-Plasma Handpiece with Retractable Cutting Blade | Bovie Medical Corporation | 2012 | — |
| +4 | K151325 | Bovie J-Plasma Handpiece | Bovie Medical Corporation | 2015 | 1 |
| +5 | K152570 | Bovie J-Plasma Precise 360 Handpiece | Bovie Medical Corporation | 2015 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAM? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030819 | Plasmajet System | 2004 | 17 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 27, 2012 | Class II | Z-0724-2013 | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030819 (Plasma Surgical, Ltd., 2004) has gone furthest, with 17 descendants of its own.
How does its category compare?
All HAM devicesHAM Apparatus, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAM
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HAM
Too few HAM 510(k)s in any year since 2007 to give a median.
Recalls per year · HAM
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAM
2in 2025
MAUDE reports naming product code HAM, 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 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K871435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K871435: Bard Ems System 6000 E.S.U..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871435
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026