Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Helps Products, 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) |
|---|---|---|---|---|---|
| K881188 | BLOOD PH CAPILLARY TUBES, HEPARIN | Helps Products, Inc. | 1988-07-08 | 109 | 0 |
| K881186 | MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL | Helps Products, Inc. | 1988-05-13 | 53 | 0 |
| K881187 | NATELSON TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 | 46 | 0 |
| K881262 | CARAWAY TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 | 43 | 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