510(k) · Cleared
ClearedB100 Disposable Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beacon Laboratories, Inc. · HAM Apparatus, Electrosurgical
Cleared on Sep 15, 1989 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.
- Decided
- Sep 15, 1989
- Review
- 50 days
- Class
- Class II
- Product code
- HAM
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 1 citing it directly.
- This deviceK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- Descendant · cites it directly · 67 of its ownK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- Descendant · 2 generations on · 30 of its ownK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
- Descendant · 2 generations on · 25 of its ownK024047 Erbe Vio Apc with AccessoriesErbe USA, Inc. · 2003
- Descendant · 2 generations on · 17 of its ownK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
- Descendant · 3 generations on · 16 of its ownK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…Erbe USA, Inc. · 1996 · cites it directly67descendants
- K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…Erbe USA, Inc. · 2001 · 2 generations on30descendants
- K024047Erbe Vio Apc with AccessoriesErbe USA, Inc. · 2003 · 2 generations on25descendants
- K030819Plasmajet SystemPlasma Surgical, Ltd. · 2004 · 2 generations on17descendants
- K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece…Bovie Medical · 2009 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| +1 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| +2 | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158… | Erbe USA, Inc. | 2001 | — |
| +2 | K024047 | Erbe Vio Apc with Accessories | Erbe USA, Inc. | 2003 | — |
| +2 | K030819 | Plasmajet System | Plasma Surgical, Ltd. | 2004 | — |
| +3 | K090586 | Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable… | Bovie Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 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? (68)
See all 681 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and… | 1996 | 67 |
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?
- Of its descendants, K963189 (Erbe USA, Inc., 1996) has gone furthest, with 67 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/K894762 · printed Nov 5, 2026
Cite this page
510(k) Report. “K894762: B100 Disposable Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894762
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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