510(k) · Cleared

Recalled · 2006

Macan Model MC-4A Dental Electrosurgical Unit

K052622510(k) TraditionalCleared Dec 9, 200577-day reviewClass II21 CFR 872.4920Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Macan Engineering Co. · EKZ Unit, Electrosurgical, And Accessories, Dental

Cleared on Dec 9, 2005 as substantially equivalent to K050735 (Macan Engineering Co., 2005) after a 77-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.

Decided: Dec 9, 2005
Review: 77 days
Class: Class II
Product code: EKZ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K950239 (1995). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK950239 Sensimatic 500SEParkell, Inc. · 1995
1 generation backK050735 MC6AMacan Engineering Co. · 2005
This deviceK052622 Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K950239	Sensimatic 500SE	Parkell, Inc.	1995	—
−1	K050735	MC6A	Macan Engineering Co.	2005	—
0 (this device)	K052622	Macan Model MC-4A Dental Electrosurgical Unit	Macan Engineering Co.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K052622, 1995–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K050735	MC6A Summary page 1 …Accessories, Dental Regulation : 872.4920 Product Code: EKZ Classification: class II 510(k) Number: 050735 SUMMARY TABLE OF COMPARISON Indications for Use SAME Electrical Output…	Macan Engineering Co.	2005	—

Also cleared against K050735: 1 other device →

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
Apr 5, 2006	Not classified	Z-0810-06	Other	The product label fails to warn users to use the device on patients with shielded pacemakers only.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K050735.

How does its category compare?

All EKZ devices

EKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKZ

1in 2022

2007high 2 (2007) · low 0 (2008)2026

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

2007high 6 (2018) · low 0 (2007)2025

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	MAUDE reports
2007	2	—	0
2008	0	—	0
2009	0	—	1
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	1
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	6
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	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/K052622 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052622: Macan Model MC-4A Dental Electrosurgical Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052622

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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