Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tecnadyne Scientific, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
150 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940431 | TECNADYNE 20/20 FOG INHIBITOR KIT | Tecnadyne Scientific, Inc. | 1994-04-29 | 88 | 0 |
| K940891 | TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER | Tecnadyne Scientific, Inc. | 1994-04-26 | 60 | 0 |
| K910926 | TECNADYNE SURGI-SQUEEZE INFUSION PUMP | Tecnadyne Scientific, Inc. | 1991-08-02 | 150 | 0 |
| K912007 | BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF | Tecnadyne Scientific, Inc. | 1991-07-22 | 77 | 0 |
| K904484 | BAXTER SINGLE PATIENT USE PRESSURE INFUSOR | Tecnadyne Scientific, Inc. | 1990-10-26 | 24 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda