International Technidyne Corp.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “International Technidyne Corp.” (first 1983, latest 2013), across 17 product codes in 3 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Werfen, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 457 |
| 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 9 | 9 |
| GJS | Test, Time, Prothrombin | 8 | 8 |
| GFO | Activated Partial Thromboplastin | 5 | 5 |
| GGN | Plasma, Coagulation Control | 4 | 4 |
| JBP | Activated Whole Blood Clotting Time | 4 | 4 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 3 | 3 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 | 3 |
| JCA | Device, Bleeding Time | 2 | 2 |
| KFF | Assay, Heparin | 2 | 2 |
| GFT | Protamine Sulphate | 1 | 1 |
Plus 7 more product codes.
Review panels
Most recent International Technidyne Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | GGN | 2013-07-03 | 457 |
| K050983 | IRMA TRUPOINT CREATININE CONTROL KIT | JJX | 2005-05-16 | 27 |
| K050016 | HEMOCHRON SIGNATURE ELITE | JPA | 2005-02-10 | 37 |
| K030818 | HEMOCHRON RESPONSE/SYSTEM | JPA | 2003-04-02 | 19 |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | GKR | 2003-01-31 | 100 |
| K020798 | HEMOCHRON JR. SIGNATURE + | JPA | 2002-03-28 | 16 |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | GJS | 2001-07-02 | 124 |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | KFF | 2001-06-06 | 135 |
| K983475 | HEMOCHRON RESPONSE | KQG | 1999-05-03 | 213 |
| K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | JPA | 1999-04-13 | 60 |
38 earlier clearances. See the full list in Caduvo.
Recalls
22 product recalls in 16 recall events; 0 initiated in the last five years. Most recent: 2012-09-28.
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.
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.
- International Imaging Electronics (19 510(k)s)
- International Biomedical (17 510(k)s)
- International Biophysics Corp. (14 510(k)s)
- International Medsurg Connection (13 510(k)s)
- International Medical Products, Inc. (9 510(k)s)
- International Newtech Development, Inc. (8 510(k)s)
- International Enzymes, Inc. (7 510(k)s)
- International Medical Industries, Inc. (7 510(k)s)
- International Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Regulatory Consultants (5 510(k)s)
- International Implant Seminars (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Technidyne Corp.?
FDA lists 48 510(k) clearances under the applicant name “International Technidyne Corp.” (first 1983, latest 2013), across 17 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 International Technidyne Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Technidyne Corp. is 90 days.
Which FDA product codes appear under International Technidyne Corp.?
The most frequent FDA product codes under this applicant name are JPA (System, Multipurpose For In Vitro Coagulation Studies, 9); GJS (Test, Time, Prothrombin, 8); GFO (Activated Partial Thromboplastin, 5).
Next steps
- See all 48 International Technidyne Corp. clearances with predicates and recalls
- Run predicate analysis for product code JPA, International Technidyne Corp.'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.