Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GLE — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
66 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823124 | IMS HEMATOLOGY MIXER | Innovative Medical Systems, Inc. | 1982-11-22 | 31 | 0 |
| K800003 | CORTEX DOUBLE HELIX SAMPLER | Cortex Research Corp. | 1980-02-01 | 30 | 0 |
| K780544 | DISC-PAK ROTATOR | Techhnilab Instruments, Inc. | 1978-04-24 | 21 | 0 |
| K771617 | SPECI-MIX | Thermolyne Corp. | 1977-09-02 | 9 | 0 |
| K770830 | PLATELET AGITATOR | Helmer Labs, Inc. | 1977-07-11 | 66 | 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