Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ppg Hellige B.V. · 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) |
|---|---|---|---|---|---|
| K921666 | CARDIAC THERAPHY SYSTEM SCP 900 | Ppg Hellige B.V. | 1993-09-23 | 534 | 0 |
| K903917 | COMPACT MONITOR SMK 210,211,230,231,240 | Ppg Hellige B.V. | 1991-01-18 | 147 | 0 |
| K903900 | SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. | Ppg Hellige B.V. | 1991-01-08 | 138 | 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