Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HGW — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891388 | 1570 - FETAL BLOOD SAMPLING KIT | Transidyne General Corp. | 1989-03-28 | 14 | 0 |
| K884685 | ROCKET FETAL BLOOD SAMPLING TRAY | A & A Medical, Inc. | 1989-01-12 | 65 | 0 |
| K831459 | FETAL BLOOD SAMPLING KIT #1560 | Transidyne General Corp. | 1983-06-30 | 55 | 0 |
| K810028 | FETAL BLOOD SAMPLING KIT MODEL 1560 | Transidyne General Corp. | 1981-01-16 | 10 | 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