Genzyme Corp.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Genzyme Corp.” (first 1991, latest 2010), plus 2 PMA decisions, across 20 product codes in 7 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | 4 | 4 |
| FTL | Mesh, Surgical, Polymeric | 3 | 3 |
| LBR | Ldl & Vldl Precipitation, Hdl | 3 | 3 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 3 | 3 |
| MRR | System, Test, Low Density, Lipoprotein | 3 | 3 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 3 | 3 |
| GGT | Assay, Erythropoietin | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| FTM | Mesh, Surgical | 1 | 1 |
Plus 10 more product codes.
Review panels
- Clinical Chemistry (16)
- General and Plastic Surgery (6)
- Microbiology (5)
- Hematology (4)
- Ear, Nose and Throat (2)
- Cardiovascular (1)
- Immunology (1)
Most recent Genzyme Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | LLH | 2010-12-21 | 134 |
| K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 | PSZ | 2009-09-25 | 29 |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | NDY | 2008-05-15 | 66 |
| K063739 | SEPRAMESH, MODEL 5959-1214 | FTL | 2007-01-17 | 30 |
| K061508 | OSOM INFLUENZA A&B TEST | PSZ | 2006-06-12 | 11 |
| K051244 | GENZYME OSOM INFLUENZA A & B TEST | PSZ | 2006-02-21 | 281 |
| K053066 | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH | FTL | 2005-12-19 | 48 |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | KHJ | 2005-07-11 | 250 |
| K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | DCK | 2004-06-25 | 143 |
| K040868 | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH | FTM | 2004-06-04 | 63 |
23 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P110003 | PMA | LEGOO | 2011-09-28 |
| P990028 | PMA | FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT | 2000-05-26 |
Recalls
9 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2012-06-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Genzyme Corp. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Genzyme Surgical Product (Genzyme Biosurgery) (9 510(k)s)
- Genzyme Diagnostics (5 510(k)s)
- Genzyme Biosurgery (4 510(k)s)
- Genzyme Diagnostics P.E.I., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genzyme Corp.?
FDA lists 33 510(k) clearances under the applicant name “Genzyme Corp.” (first 1991, latest 2010), plus 2 PMA decisions, across 20 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Genzyme Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genzyme Corp. is 74 days.
Which FDA product codes appear under Genzyme Corp.?
The most frequent FDA product codes under this applicant name are JFJ (Catalytic Methods, Amylase, 4); FTL (Mesh, Surgical, Polymeric, 3); LBR (Ldl & Vldl Precipitation, Hdl, 3).
Next steps
- See all 33 Genzyme Corp. clearances with predicates and recalls
- Run predicate analysis for product code JFJ, Genzyme Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.