Cederroth, Inc. USA: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cederroth, Inc. USA” (first 1982, latest 1988), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| LKB | Pad, Alcohol, Device Disinfectant | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Cederroth, Inc. USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880788 | NON ADHERENT PAD | FRO | 1988-04-01 | 35 |
| K823057 | MEDICATED ADHESIVE STRIP | — | 1983-03-31 | 164 |
| K830330 | SAVETT ALCOHOL PREP | LKB | 1983-03-17 | 44 |
| K820059 | RESUSCITATION MASK | BTM | 1982-03-26 | 74 |
| K813365 | MULTIPLE BANDAGE OR DRESSING | FRO | 1982-02-04 | 66 |
| K813364 | MEDICAL TAPE (MULTIPLE) | KGX | 1982-01-19 | 50 |
| K813361 | ADHESIVE STRIP(MULTIPLE) | KGX | 1982-01-18 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Cederroth, Inc. USA.
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 Cederroth, Inc. USA?
FDA lists 7 510(k) clearances under the applicant name “Cederroth, Inc. USA” (first 1982, latest 1988), across 5 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 Cederroth, Inc. USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cederroth, Inc. USA is 50 days.
Which FDA product codes appear under Cederroth, Inc. USA?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 2); KGX (Tape And Bandage, Adhesive, 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Next steps
- See all 7 Cederroth, Inc. USA clearances with predicates and recalls
- Run predicate analysis for product code FRO, Cederroth, Inc. USA'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.