Cis-Us, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Cis-Us, Inc.” (first 1986, latest 1995), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | 1 | 1 |
| IYT | System, Rebreathing, Radionuclide | 1 | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 | 1 |
| JKR | Radioimmunoassay, Calcitonin | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KPY | Shield, Protective, Personnel | 1 | 1 |
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | 1 | 1 |
Review panels
- Radiology (5)
- Clinical Chemistry (4)
Most recent Cis-Us, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951708 | ELSA-HCT | JKR | 1995-09-05 | 145 |
| K950211 | ELSA-PTH | CEW | 1995-04-13 | 84 |
| K890799 | CURIETRON 192 HIGH DOSE RATE | JAQ | 1989-10-27 | 252 |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | IWI | 1989-04-14 | 304 |
| K871502 | PERSONNEL PROTECTIVE SHIELD | KPY | 1987-05-08 | 21 |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | MOT | 1987-02-26 | 65 |
| K863778 | VENTICIS II | IYT | 1986-10-27 | 31 |
| K860823 | ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT | CFT | 1986-08-19 | 168 |
| K860824 | TSHK-NN RIA KIT | JLW | 1986-04-28 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Cis-Us, 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 Cis-Us, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Cis-Us, Inc.” (first 1986, latest 1995), across 9 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 Cis-Us, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cis-Us, Inc. is 84 days.
Which FDA product codes appear under Cis-Us, Inc.?
The most frequent FDA product codes under this applicant name are CEW (Radioimmunoassay, Parathyroid Hormone, 1); CFT (Radioimmunoassay, Prolactin (Lactogen), 1); IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum, 1).
Next steps
- See all 9 Cis-Us, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEW, Cis-Us, 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.