# K143068: Medical Monofilament Sensory Screening Toool

- Pathway: 510(k) (Traditional)
- Applicant: Medical Monofilament Manufacturing
- Decided: Jan 14, 2015 after 82 days
- Product code: GXB (Esthesiometer)
- Device class: 1
- Regulation: 21 CFR 882.1500
- 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) Medical Monofilament Sensory Testing Filament: named in the summary without a submission number

## Indications for use
The Fit2Walk Monofilament Sensory Screening Tool is intended to be used to determine whether a person with diabetes has the presence of an adequate level of protective sensation in their feet as indicated by having enough tactile sensitivity in order to perceive 10 grams of force against the skin of their feet. It is indicated for use by adult Diabetic patients on a periodic basis to evaluate changes in sensory perception in the feet due to Diabetic peripheral sensory neuropathy. This device is not to be considered a replacement for routine sensory evaluation by a health care provider.

Source page: https://510kreport.com/device/K143068
Methodology: https://510kreport.com/methodology