510(k) · Cleared
ClearedMedical Monofilament Sensory Screening Toool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Monofilament Manufacturing · GXB Esthesiometer
Cleared on Jan 14, 2015 after an 82-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 14, 2015
- Review
- 82 days
- Class
- Class I
- Product code
- GXB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Planning a device in GXB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Medical Monofilament Sensory Testing Filament 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 GXB devicesGXB Esthesiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GXB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · GXB
Too few GXB 510(k)s in any year since 2007 to give a median.
Recalls per year · GXB
No recall names GXB since 2007.
Adverse event reports per year · GXB
1in 2025
MAUDE reports naming product code GXB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143068: Medical Monofilament Sensory Screening Toool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143068
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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