Gelman Sciences, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Gelman Sciences, Inc.” (first 1979, latest 1995), across 18 product codes in 8 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| JJN | Apparatus, Electrophoresis, For Clinical Use | 5 | 5 |
| FMF | Syringe, Piston | 4 | 4 |
| FPB | Filter, Infusion Line | 3 | 3 |
| JRL | Unit, Filter, Membrane | 3 | 3 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 2 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (14)
- General Hospital (7)
- Cardiovascular (3)
- Clinical Toxicology (3)
- Hematology (2)
- Gastroenterology and Urology (1)
- Immunology (1)
- Microbiology (1)
Most recent Gelman Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946190 | DRUG DISPENSING SPIKE | FMF | 1995-03-17 | 87 |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | FPB | 1994-09-29 | 92 |
| K941589 | SYRINGE FILTER DEVICES | FMF | 1994-09-06 | 159 |
| K941020 | DRUG RECONSTITUTION FILTER DEVICE | FMF | 1994-08-10 | 160 |
| K942275 | VIAL VENT FILTER | FPB | 1994-07-26 | 77 |
| K941032 | UNKNOWN | FMF | 1994-05-27 | 81 |
| K910821 | TRANSDUCER PROTECTOR | FIB | 1991-08-12 | 167 |
| K892387 | MODIFIED GELMAN ARTERIAL FILTER | DTM | 1989-06-22 | 69 |
| K884176 | CHROMATOGRAPHY KIT | DPA | 1989-04-04 | 182 |
| K884178 | DRUG CONTROL SET | DIF | 1989-02-17 | 136 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gelman Sciences, Inc..
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.
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.
- Gelman Instrument Co. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gelman Sciences, Inc.?
FDA lists 32 510(k) clearances under the applicant name “Gelman Sciences, Inc.” (first 1979, latest 1995), across 18 product codes in 8 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 Gelman Sciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gelman Sciences, Inc. is 46 days.
Which FDA product codes appear under Gelman Sciences, Inc.?
The most frequent FDA product codes under this applicant name are JJN (Apparatus, Electrophoresis, For Clinical Use, 5); FMF (Syringe, Piston, 4); FPB (Filter, Infusion Line, 3).
Next steps
- See all 32 Gelman Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJN, Gelman Sciences, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.