Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genzyme Corporation — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
250 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | Genzyme Corporation | 2010-12-21 | 134 | 1 |
| K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 | Genzyme Corporation | 2009-09-25 | 29 | 0 |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | 2008-05-15 | 66 | 0 |
| K063739 | SEPRAMESH, MODEL 5959-1214 | Genzyme Corporation | 2007-01-17 | 30 | 0 |
| K053066 | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH | Genzyme Corporation | 2005-12-19 | 48 | 0 |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | Genzyme Corporation | 2005-07-11 | 250 | 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