Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KHM · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
84 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831295 | AMYLASE REAGENT #88129 | Hi Chem, Inc. | 1983-06-30 | 71 | 0 |
| K812699 | AMYLASE | Pointe Scientific, Inc., | 1981-10-06 | 14 | 0 |
| K812447 | AMYLASE REAGENT KIT | Bioscientific | 1981-09-09 | 12 | 0 |
| K801096 | PERKIN ELMER MODEL 91 AMYLASE REAGENT | Stat Engineering | 1980-06-09 | 31 | 0 |
| K790797 | AMYLASE REAGENT SET | Alta Diagnostics, Inc. | 1979-07-17 | 84 | 0 |
| K770400 | REAGENT, AMYLASE LIPASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 | 55 | 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