Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arbrook Mfg. Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
45 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K792016 | DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL | Arbrook Mfg. Corp. | 1979-10-26 | 21 | 0 |
| K781847 | LATEX, IN-HOUSE COMPOUNDED | Arbrook Mfg. Corp. | 1978-11-03 | 1 | 0 |
| K781278 | GLOVES, PROCEDURE | Arbrook Mfg. Corp. | 1978-08-31 | 37 | 0 |
| K770056 | GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE | Arbrook Mfg. Corp. | 1977-02-25 | 45 | 0 |
| K760421 | THERMOMETER, SURVALENT-ELECTRONIC | Arbrook Mfg. Corp. | 1976-08-23 | 13 | 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