Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Harwill Medical (Pty) , Ltd. — 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) |
|---|---|---|---|---|---|
| K992618 | RESPALERT | Harwill Medical (Pty) , Ltd. | 1999-10-29 | 86 | 0 |
| K983202 | HARWILL MEDICAL CERVITULA CERVICAL SPATULA | Harwill Medical (Pty) , Ltd. | 1999-03-15 | 182 | 0 |
| K983204 | HARWILL MEDICAL U-KLIP UMBILICAL CLAMP | Harwill Medical (Pty) , Ltd. | 1999-02-26 | 165 | 0 |
| K980550 | WHISTLE WATCH | Harwill Medical (Pty) , Ltd. | 1998-08-27 | 196 | 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