Teknar, Inc.: FDA clearances and approvals
Teknar, Inc. has 18 FDA 510(k) clearances (first 1980, latest 1990), across 9 product codes in 5 review panels. Median 510(k) review time: 92 days.
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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 9 | 9 |
| EPT | Microscope, Surgical | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 1 | 1 |
| HDR | Cap, Cervical | 1 | 1 |
| HPY | Unit, Electrolysis, Battery-Powered, Ophthalmic | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (10)
- Ophthalmic (2)
- General and Plastic Surgery (2)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Teknar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903666 | OPHTHASONIC A/P III | HPY | 1990-11-19 | 97 |
| K896038 | B-SCAN 10 MHZ PROBE | ITX | 1990-04-23 | 189 |
| K896150 | IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC | IYO | 1990-01-18 | 87 |
| K891777 | PRO-CUT BIOPSY NEEDLE | FCG | 1989-05-04 | 41 |
| K883965 | PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR | IYO | 1988-10-05 | 15 |
| K881850 | TEKNAR PERCU-SCAN | IYO | 1988-08-29 | 119 |
| K881605 | BIOPSY GUIDE | IYO | 1988-06-21 | 84 |
| K880659 | TEKNAR PROSCAN ACCESSORY PROBE | IYO | 1988-04-14 | 57 |
| K871536 | OPHTHASONIC A-SCAN/ B-SCAN | IYO | 1987-08-26 | 128 |
| K864807 | TEKNAR PROSCAN(TM) | IYO | 1987-07-10 | 213 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Teknar, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Teknar, Inc. have?
Teknar, Inc. has 18 FDA 510(k) clearances (first 1980, latest 1990), across 9 product codes in 5 review panels.
How long does FDA take to clear Teknar, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Teknar, Inc.'s cleared 510(k)s is 92 days.
What devices does Teknar, Inc. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 9); EPT (Microscope, Surgical, 1); FCG (Biopsy Needle, 1).
Has Teknar, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Teknar, Inc. Related entities may recall under other names.
Next steps
- See all 18 Teknar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Teknar, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.