Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GXB — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
261 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143068 | Medical Monofilament Sensory Screening Toool | Medical Monofilament Manufacturing | 2015-01-14 | 82 | 0 |
| K933798 | NU-PREP GEL | Cadwell Laboratories, Inc. | 1994-04-22 | 261 | 0 |
| K871571 | NEUROTIPS(TM) | Ulster Scientific, Inc. | 1987-06-18 | 57 | 0 |
| K801907 | ALGESIOMETER | Rowan Products, Inc. | 1980-09-16 | 36 | 0 |
| K772406 | AESTHESIOMETER | Fred Sammons, Inc. | 1978-01-06 | 10 | 0 |
| K771847 | TEMP-TESTER | Jablecki, Charles, Dr. | 1977-11-02 | 35 | 0 |
| K761133 | AESTHESIOMETER | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda