Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hf Scientific, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
130 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882801 | RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. | Hf Scientific, Inc. | 1988-08-29 | 53 | 0 |
| K880967 | MICRO CO2 APPARATUS | Hf Scientific, Inc. | 1988-04-28 | 51 | 0 |
| K874429 | HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 | Hf Scientific, Inc. | 1988-02-04 | 99 | 0 |
| K864313 | CO2 REAGENT SET | Hf Scientific, Inc. | 1987-03-13 | 130 | 0 |
| K864862 | REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. | Hf Scientific, Inc. | 1987-02-20 | 71 | 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