Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Swemed Lab International AB — 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) |
|---|---|---|---|---|---|
| K053208 | CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B | Swemed Lab International AB | 2006-01-30 | 75 | 0 |
| K022643 | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | Swemed Lab International AB | 2002-11-05 | 89 | 0 |
| K991273 | SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, | Swemed Lab International AB | 1999-08-18 | 127 | 0 |
| K991700 | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTI | Swemed Lab International AB | 1999-07-19 | 62 | 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