Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hart Enterprises, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921683 | PENCIL POINT SPINAL NEEDLE | Hart Enterprises, Inc. | 1993-08-26 | 505 | 0 |
| K913815 | AUTOMATED BIOPSY DEVICE, MODIFICATION | Hart Enterprises, Inc. | 1991-10-30 | 65 | 0 |
| K885149 | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE | Hart Enterprises, Inc. | 1989-01-26 | 42 | 0 |
| K881730 | BREAST LOCALIZATION NEEDLES | Hart Enterprises, Inc. | 1988-05-13 | 21 | 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