Tech-Cons Ltd., Intl.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Tech-Cons Ltd., Intl.” (first 1984, latest 1984), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Tech-Cons Ltd., Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843117 | GREEN CROSS URINARY DRAINAGE BAG | KNX | 1984-10-11 | 64 |
| K843035 | SANG-A PETROLATUM GAUZE USP STERILE | FRO | 1984-09-20 | 49 |
| K842228 | AIMED FOLEY CATHETER VARIOUS SIZES | KOD | 1984-09-10 | 97 |
| K842255 | AIMED SCALP VEIN SET VARIOUS | — | 1984-08-17 | 71 |
| K842230 | AIMED DISPOS. INJECTION NEEDLE | GAA | 1984-08-17 | 73 |
| K842227 | AIMED DISPOSABLE SYRINGE, VARIOUS SIZES | FMF | 1984-07-23 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Tech-Cons Ltd., Intl..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tech-Cons Ltd., Intl.?
FDA lists 6 510(k) clearances under the applicant name “Tech-Cons Ltd., Intl.” (first 1984, latest 1984), 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 Tech-Cons Ltd., Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tech-Cons Ltd., Intl. is 68 days.
Which FDA product codes appear under Tech-Cons Ltd., Intl.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 1); FRO (Dressing, Wound, Drug, 1); GAA (Needle, Aspiration And Injection, Disposable, 1).
Next steps
- See all 6 Tech-Cons Ltd., Intl. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Tech-Cons Ltd., Intl.'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.