Arjo-Century, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Arjo-Century, Inc.” (first 1992, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| ILJ | Bath, Hydro-Massage | 4 | 4 |
| FNG | Lift, Patient, Ac-Powered | 1 | 1 |
| FRW | Scale, Patient | 1 | 1 |
Review panels
Most recent Arjo-Century, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930665 | CENTURY BATHING SYSTEM | ILJ | 1995-08-28 | 930 |
| K926411 | SAF-LIFT/SAF-KARY | FNG | 1993-03-31 | 100 |
| K923637 | ARJO-CENTURY ARM AND LEG TANK SYSTEM | ILJ | 1993-02-12 | 206 |
| K923617 | FULL MOVEMENT THERAPY SYSTEMS | ILJ | 1992-11-09 | 111 |
| K923159 | ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS | ILJ | 1992-08-06 | 38 |
| K920074 | ARJO CENTURY SCALES WITH REMOTE | FRW | 1992-04-06 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Arjo-Century, 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 Arjo-Century, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Arjo-Century, Inc.” (first 1992, latest 1995), across 3 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 Arjo-Century, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arjo-Century, Inc. is 106 days.
Which FDA product codes appear under Arjo-Century, Inc.?
The most frequent FDA product codes under this applicant name are ILJ (Bath, Hydro-Massage, 4); FNG (Lift, Patient, Ac-Powered, 1); FRW (Scale, Patient, 1).
Next steps
- See all 6 Arjo-Century, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILJ, Arjo-Century, 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.