510(k) · Cleared
ClearedMC6A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macan Engineering Co. · EKZ Unit, Electrosurgical, And Accessories, Dental
Cleared on May 23, 2005 as substantially equivalent to K955176 (Ellman Intl., Inc., 1996) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- May 23, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- EKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950239 (1995). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK950239 Sensimatic 500SEParkell, Inc. · 1995
- This deviceK050735 MC6AMacan Engineering Co. · 2005
- Descendant · cites it directly · 0 of its ownK170054 iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America · 2017
- Descendant · cites it directly · 0 of its ownK052622 Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co. · 2005 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950239 | Sensimatic 500SE | Parkell, Inc. | 1995 | — |
| 0 (this device) | K050735 | MC6A | Macan Engineering Co. | 2005 | — |
| +1 | K170054 | iSurg | Jaco, LLC Dba Macan Manufacturing and Bna Burz North America | 2017 | — |
| +1 | K052622 | Macan Model MC-4A Dental Electrosurgical Unit | Macan Engineering Co. | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2017 | 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 EKZ? 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 EKZ device
- #1 K213477 Root ZX3score 5.3 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K955176 | Dento-SurgeSummary page 1…ng upon the operating mode selected, either cuts through soft tissue or coagulates the tissue. Predicate Substantially Equivalent Devices K955176 K950239 Ellman Int'l Parkel… | 1996 |
| * | K950239 | Sensimatic 500SESummary page 1…t tissue or coagulates the tissue. Predicate Substantially Equivalent Devices K955176 K950239 Ellman Int'l Parkell Dento-surge 9OFFP… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K170054 (Jaco, LLC Dba Macan Manufacturing and Bna Burz North America, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EKZ devicesEKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EKZ
Too few EKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · EKZ
No recall names EKZ since 2007.
Adverse event reports per year · EKZ
6in 2018
MAUDE reports naming product code EKZ, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Soft tissue management within the oral cavity to address the indications for incision, excision and coagulation to induce hemostasis in intra-oral soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050735: MC6A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050735
Report an extraction error
Are you the manufacturer?
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