510(k) Report

510(k) · Cleared

Cleared

Pathformer

K052770510(k) TraditionalCleared Oct 31, 200531-day reviewClass I21 CFR 878.4820

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

Path Scientific, LLC · NWF Drill, Battery Powered, Subungual Hematoma

Cleared on Oct 31, 2005 after a 31-day review. The FDA summary names its predicate without a number.

Decided
Oct 31, 2005
Review
31 days
Class
Class I
Product code
NWF
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K052770Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—Nail Leezer First Aid Manual Trephinating Drill
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All NWF devices

NWF Drill, Battery Powered, Subungual Hematoma: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NWF

FDA has decided no NWF device since 2007.

Median 510(k) review, days · NWF

Too few NWF 510(k)s in any year since 2007 to give a median.

Recalls per year · NWF

No recall names NWF since 2007.

Adverse event reports per year · NWF

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code NWF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K052770 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052770: Pathformer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052770

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026