# K862221: E-Z Clean

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Products, Inc.
- Decided: Sep 12, 1986 after 93 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081791: E-Z Clean Electrosurgical Electrode (2008), 8 descendants of its own
- K091672: Disposable Grounding Pad Series and Electrode Series (2009), 3 descendants of its own
- K220725: HPR45i (2023), 1 descendant of its own
- K152059: Disposable General Electrode (2016), 1 descendant of its own
- K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K862221
Methodology: https://510kreport.com/methodology