Tecnadyne Scientific, Inc.: FDA clearances and approvals
Tecnadyne Scientific, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1994), across 3 product codes in 3 review panels. Median 510(k) review time: 77 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| KZD | Infusor, Pressure, For I.V. Bags | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Review panels
Most recent Tecnadyne Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940431 | TECNADYNE 20/20 FOG INHIBITOR KIT | GCJ | 1994-04-29 | 88 |
| K940891 | TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER | GCJ | 1994-04-26 | 60 |
| K910926 | TECNADYNE SURGI-SQUEEZE INFUSION PUMP | KZD | 1991-08-02 | 150 |
| K912007 | BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF | DXQ | 1991-07-22 | 77 |
| K904484 | BAXTER SINGLE PATIENT USE PRESSURE INFUSOR | KZD | 1990-10-26 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Tecnadyne Scientific, 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 Tecnadyne Scientific, Inc. have?
Tecnadyne Scientific, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1994), across 3 product codes in 3 review panels.
How long does FDA take to clear Tecnadyne Scientific, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tecnadyne Scientific, Inc.'s cleared 510(k)s is 77 days.
What devices does Tecnadyne Scientific, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 2); KZD (Infusor, Pressure, For I.V. Bags, 2); DXQ (Blood Pressure Cuff, 1).
Has Tecnadyne Scientific, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tecnadyne Scientific, Inc. Related entities may recall under other names.
Next steps
- See all 5 Tecnadyne Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Tecnadyne Scientific, 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.