Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Techhnilab Instruments, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
53 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813523 | ELECTRIC SELF STERILIZATION INOCUL. LOOP | Techhnilab Instruments, Inc. | 1981-12-31 | 15 | 0 |
| K780543 | THERMAJUST CIRCU-TEMP | Techhnilab Instruments, Inc. | 1978-05-26 | 53 | 0 |
| K780544 | DISC-PAK ROTATOR | Techhnilab Instruments, Inc. | 1978-04-24 | 21 | 0 |
| K771434 | MULTI-CAVITY EQUILIBRIUM CELL | Techhnilab Instruments, Inc. | 1977-08-22 | 21 | 0 |
| K770169 | BEESON AUTOMADDAK FEEDER | Techhnilab Instruments, Inc. | 1977-01-28 | 3 | 0 |
| K770170 | MADDATHERM PARAFFIN BATH | Techhnilab Instruments, Inc. | 1977-01-28 | 3 | 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