Advocacy International, Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Advocacy International, Ltd.” (first 1981, latest 1988), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | 3 | 3 |
| CAK | Microfilter, Blood Transfusion | 2 | 2 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | 1 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 | 1 |
Review panels
Most recent Advocacy International, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874027 | LIPASE UV [TOYO] | CHI | 1988-05-27 | 238 |
| K873792 | SEPACELL R-500 AND SEPACELL R-500A | CAK | 1988-01-19 | 124 |
| K855251 | MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS | KDI | 1986-02-04 | 36 |
| K855212 | ASAHI AM SERIES DIALYZERS | FJI | 1986-01-21 | 22 |
| K854259 | SEPACELL R-500 & SEPACELL R-500A | CAK | 1986-01-08 | 77 |
| K842103 | TOYO JOZO URIC ACID TEST | KNK | 1984-08-12 | 79 |
| K842104 | TOYO JOZO G-GTP TEST | JPZ | 1984-08-10 | 77 |
| K830231 | ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES | KOC | 1983-03-17 | 58 |
| K830183 | ASAHI HOLLOW FIBER KIDNEYS NR SERIES | KOC | 1983-03-17 | 58 |
| K823733 | EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR | KOC | 1983-01-14 | 32 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advocacy International, Ltd..
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 Advocacy International, Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Advocacy International, Ltd.” (first 1981, latest 1988), across 10 product codes in 4 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 Advocacy International, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advocacy International, Ltd. is 58 days.
Which FDA product codes appear under Advocacy International, Ltd.?
The most frequent FDA product codes under this applicant name are KOC (Accessories, Blood Circuit, Hemodialysis, 3); CAK (Microfilter, Blood Transfusion, 2); CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase, 1).
Next steps
- See all 13 Advocacy International, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KOC, Advocacy International, Ltd.'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.