# K920357: Ultracell Ear Wick

- Pathway: 510(k) (Traditional)
- Applicant: Ultracell Medical Technologies, Inc.
- Decided: Feb 1, 1993 after 371 days
- Product code: KCN (Ear Wick)
- Device class: 1
- Regulation: 21 CFR 874.5220
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 25, 2022 · Class II · Z-1625-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Jan 8, 2003 · Not classified · Z-0480-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0481-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0482-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0483-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0485-03: Sterility of the device is compromised

Source page: https://510kreport.com/device/K920357
Methodology: https://510kreport.com/methodology