# K822277: Rosen's Stapes Needle Explorer

- Pathway: 510(k) (Traditional)
- Applicant: Kelleher Corp.
- Decided: Aug 25, 1982 after 27 days
- Product code: KAK (Probe, Ent)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: 1 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 17, 2012 · Class II · Z-0407-2013: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

Source page: https://510kreport.com/device/K822277
Methodology: https://510kreport.com/methodology