Supelco, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Supelco, Inc.” (first 1976, latest 1989), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| DPM | Columns, Liquid Chromatography | 10 | 10 |
| DII | Columns, Glc | 3 | 3 |
| DKB | Calibrators, Drug Mixture | 3 | 3 |
| DJY | Ion-Exchange Chromatography | 2 | 2 |
| JIS | Calibrator, Primary | 2 | 2 |
| DAS | Igg (Fc Fragment Specific), Antigen, Antiserum, Control | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DJA | Column Supports, Glc | 1 | 1 |
| JSQ | Chromatography For Bacterial Identification | 1 | 1 |
Review panels
- Clinical Toxicology (21)
- Clinical Chemistry (2)
- Immunology (1)
Most recent Supelco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894141 | LIQUID CHROMATOGRAPHY COLUMNS | DPM | 1989-08-21 | 69 |
| K884403 | LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE | DPM | 1988-12-22 | 64 |
| K883615 | LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 | DJY | 1988-12-16 | 114 |
| K881868 | LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD | DPM | 1988-08-29 | 118 |
| K881361 | SOLID PHASE EXTRACTION TUBES | DJY | 1988-08-08 | 174 |
| K880724 | LIQUID CHROMATO. COLUMNS | DPM | 1988-05-27 | 95 |
| K874824 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | DII | 1988-01-21 | 58 |
| K871174 | 4-9295 BARBITURATES TEST MIX | DKB | 1987-06-11 | 79 |
| K862542 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | DII | 1986-08-04 | 32 |
| K862541 | LIQUID CHROMATOGRAPHY COLUMNS | DPM | 1986-07-29 | 26 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Supelco, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Supelco, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Supelco, Inc.” (first 1976, latest 1989), across 9 product codes in 3 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 Supelco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Supelco, Inc. is 34 days.
Which FDA product codes appear under Supelco, Inc.?
The most frequent FDA product codes under this applicant name are DPM (Columns, Liquid Chromatography, 10); DII (Columns, Glc, 3); DKB (Calibrators, Drug Mixture, 3).
Next steps
- See all 24 Supelco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPM, Supelco, 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, 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.