Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocorp Production · 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) |
|---|---|---|---|---|---|
| K251500 | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | 2025-06-09 | 25 | 0 |
| K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | 2025-03-27 | 30 | 0 |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | 2024-01-12 | 205 | 0 |
| K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | 2022-12-05 | 90 | 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