# K052770: Pathformer

- Pathway: 510(k) (Traditional)
- Applicant: Path Scientific, LLC
- Decided: Oct 31, 2005 after 31 days
- Product code: NWF (Drill, Battery Powered, Subungual Hematoma)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Nail Leezer First Aid Manual Trephinating Drill: named in the summary without a submission number

## Indications for use
The PathFormer device is intended for use in relieving pressure from subungual hematomas (including black toe). It cuts through finger and toe nails to release fluid accumulated in the underlying nail bed.

Source page: https://510kreport.com/device/K052770
Methodology: https://510kreport.com/methodology