Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tridak Division of Indicon, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
465 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891007 | NONIMPLANTED ELECTRICAL CONTINENCE DEVICE | Tridak Division of Indicon, Inc. | 1990-06-07 | 465 | 0 |
| K860744 | OPTHALMIC SURGICAL INSTRUMENTS | Tridak Division of Indicon, Inc. | 1986-03-31 | 32 | 0 |
| K853059 | LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE | Tridak Division of Indicon, Inc. | 1986-01-10 | 175 | 0 |
| K852856 | LABORIE URODYNAMICS PROCESSOR | Tridak Division of Indicon, Inc. | 1985-10-17 | 104 | 0 |
| K851934 | CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA | Tridak Division of Indicon, Inc. | 1985-07-05 | 60 | 0 |
| K842609 | R.L. MEDICAL TWIN LIGHT SOURCE | Tridak Division of Indicon, Inc. | 1984-08-09 | 35 | 0 |
| K840605 | LABORIE FIBREOPTIC LIGHT CABLE | Tridak Division of Indicon, Inc. | 1984-04-13 | 63 | 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