Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Howard Associates, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892085 | PATIENT EXAMINATION GLOVES (LATEX) | Howard Associates, Inc. | 1990-02-13 | 316 | 0 |
| K891174 | PATIENT EXAMINATION GLOVES (LATEX) | Howard Associates, Inc. | 1989-07-14 | 130 | 0 |
| K855160 | CARE IV BURN PAD, CATALOG #'S BP2334,BP3472 | Howard Associates, Inc. | 1986-01-24 | 29 | 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