Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baldur Systems Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
153 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981823 | OPERATING ROOM TOWELS | Baldur Systems Corp. | 1998-08-11 | 81 | 0 |
| K974347 | BALDUR NON-STERILE COTTON SPONGES | Baldur Systems Corp. | 1998-02-10 | 83 | 0 |
| K892684 | PATIENT EXAMINATION GLOVES (LATEX) | Baldur Systems Corp. | 1989-09-11 | 153 | 0 |
| K891728 | LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) | Baldur Systems Corp. | 1989-05-25 | 63 | 0 |
| K891726 | VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) | Baldur Systems Corp. | 1989-05-12 | 50 | 0 |
| K891727 | LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD) | Baldur Systems Corp. | 1989-05-12 | 50 | 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