Tridak Division of Indicon, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Tridak Division of Indicon, Inc.” (first 1984, latest 1990), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 63 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 | 2 |
| FCW | Light Source, Fiberoptic, Routine | 1 | 1 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent Tridak Division of Indicon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891007 | NONIMPLANTED ELECTRICAL CONTINENCE DEVICE | KPI | 1990-06-07 | 465 |
| K860744 | OPTHALMIC SURGICAL INSTRUMENTS | HMX | 1986-03-31 | 32 |
| K853059 | LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE | FAP | 1986-01-10 | 175 |
| K852856 | LABORIE URODYNAMICS PROCESSOR | FAP | 1985-10-17 | 104 |
| K851934 | CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA | HHT | 1985-07-05 | 60 |
| K842609 | R.L. MEDICAL TWIN LIGHT SOURCE | FCW | 1984-08-09 | 35 |
| K840605 | LABORIE FIBREOPTIC LIGHT CABLE | FFS | 1984-04-13 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Tridak Division of Indicon, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Tridak Division of Indicon, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tridak (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tridak Division of Indicon, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Tridak Division of Indicon, Inc.” (first 1984, latest 1990), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tridak Division of Indicon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tridak Division of Indicon, Inc. is 63 days.
Which FDA product codes appear under Tridak Division of Indicon, Inc.?
The most frequent FDA product codes under this applicant name are FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 2); FCW (Light Source, Fiberoptic, Routine, 1); FFS (Image, Illumination, Fiberoptic, For Endoscope, 1).
Next steps
- See all 7 Tridak Division of Indicon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAP, Tridak Division of Indicon, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.