Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EIX — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
217 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960245 | VIP VICTOR INTERACTIVE PROBE | Pro-Dentec | 1996-04-04 | 79 | 0 |
| K944848 | THE VIVACARE T.P.S. PROBE | Rms Div. | 1994-12-14 | 75 | 0 |
| K936221 | PROBE TIP/PERI PROBE/PERI PROBE COMP. | Pd International AB | 1994-08-01 | 217 | 0 |
| K890333 | ALBUMIN REAGENT | Alpkem Corp. | 1989-02-17 | 25 | 0 |
| K880827 | ACCUTEK PERIODONTAL PROBE | Sweet Micro Systems, Inc. | 1988-04-12 | 42 | 0 |
| K875076 | FLORIDA PROBE | Florida Probe Corp. | 1988-03-10 | 92 | 0 |
| K870280 | ACCUDENT ACCUPROBE | Accudent, Inc. | 1987-06-08 | 132 | 0 |
| K871504 | DISPOSABLE PERIODONTAL PROBE | Periodontal Health Brush, Inc. | 1987-05-06 | 19 | 0 |
| K823324 | DENTAL INSTRUMENTS - PROBES | Miltex, Inc. | 1982-11-24 | 16 | 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