Hycel, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Hycel, Inc.” (first 1976, latest 1980), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 5 | 5 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 2 | 2 |
| CCY | Zimmerman (Spectrophotometric), 17-Ketosteroids | 1 | 1 |
| CDB | Porter Silber Hydrazone, 17-Hydroxycorticosteroids | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| GKK | Cyanomethemoglobin | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (13)
- Hematology (7)
Most recent Hycel, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | — | 1980-10-06 | 0 |
| K790335 | HYCEL M | JJF | 1979-02-27 | 6 |
| K782176 | HYCEL LDH-INT TEST | CFH | 1979-01-26 | 29 |
| K782116 | KETOSTEROID TEST, HYCEL-17 | CCY | 1979-01-26 | 30 |
| K782102 | HYCEL COUNTER 211 | GKL | 1979-01-03 | 16 |
| K782101 | HYCEL COUNTER 222 | GKL | 1979-01-03 | 16 |
| K782100 | HYCEL COUNTER 333 | GKL | 1979-01-03 | 16 |
| K781004 | HMA URIC ACID TEST | KNK | 1978-07-27 | 41 |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | JPJ | 1978-07-27 | 48 |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | JJE | 1978-05-03 | 42 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hycel, 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 Hycel, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Hycel, Inc.” (first 1976, latest 1980), across 16 product codes in 2 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 Hycel, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hycel, Inc. is 32 days.
Which FDA product codes appear under Hycel, Inc.?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 5); CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, 2); CCY (Zimmerman (Spectrophotometric), 17-Ketosteroids, 1).
Next steps
- See all 22 Hycel, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKL, Hycel, 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.