Baldur Systems Corp.: FDA clearances and approvals
Baldur Systems Corp. has 6 FDA 510(k) clearances (first 1989, latest 1998), across 4 product codes in 2 review panels. Median 510(k) review time: 72 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
Review panels
Most recent Baldur Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981823 | OPERATING ROOM TOWELS | KKX | 1998-08-11 | 81 |
| K974347 | BALDUR NON-STERILE COTTON SPONGES | EFQ | 1998-02-10 | 83 |
| K892684 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-09-11 | 153 |
| K891728 | LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) | LYY | 1989-05-25 | 63 |
| K891727 | LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD) | LYY | 1989-05-12 | 50 |
| K891726 | VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) | LYZ | 1989-05-12 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Baldur Systems Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Baldur Systems Corp. have?
Baldur Systems Corp. has 6 FDA 510(k) clearances (first 1989, latest 1998), across 4 product codes in 2 review panels.
How long does FDA take to clear Baldur Systems Corp.'s 510(k)s?
The median time from FDA receipt to decision across Baldur Systems Corp.'s cleared 510(k)s is 72 days.
What devices does Baldur Systems Corp. make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 3); EFQ (Gauze/Sponge, Internal, 1); KKX (Drape, Surgical, Antimicrobial, 1).
Has Baldur Systems Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Baldur Systems Corp. Related entities may recall under other names.
Next steps
- See all 6 Baldur Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Baldur Systems Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.