Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kenlor Industries, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
147 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964014 | KENLOR H. PYLORI CONTROL SERUM | Kenlor Industries, Inc. | 1997-03-03 | 147 | 0 |
| K952840 | KENLOR LIQUID TOTAL URINE CONTROL | Kenlor Industries, Inc. | 1995-07-19 | 28 | 0 |
| K950326 | KENLOR HUMAN SPINAL FLUID CONTROL | Kenlor Industries, Inc. | 1995-03-20 | 61 | 0 |
| K903338 | KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL | Kenlor Industries, Inc. | 1990-09-07 | 44 | 0 |
| K896440 | KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT | Kenlor Industries, Inc. | 1990-02-16 | 99 | 0 |
| K890618 | COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT | Kenlor Industries, Inc. | 1989-05-22 | 104 | 0 |
| K890573 | KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT | Kenlor Industries, Inc. | 1989-03-24 | 46 | 0 |
| K890577 | KENLOR LIQUID URINE CONTROL | Kenlor Industries, Inc. | 1989-03-09 | 31 | 0 |
| K890576 | KENLOR HUMAN SPINAL FLUID CONTROL LIQUID | Kenlor Industries, Inc. | 1989-03-09 | 31 | 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