Medisystems Corp.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Medisystems Corp.” (first 1981, latest 2007), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| FIE | Needle, Fistula | 6 | 6 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 5 | 5 |
| FIB | Protector, Transducer, Dialysis | 3 | 3 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 | 1 |
Review panels
Most recent Medisystems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | FIE | 2007-02-12 | 136 |
| K010279 | MEDISYSTEMS LUER ACCESS INJECTION SITE | FPA | 2001-05-29 | 119 |
| K002372 | ACCESS ALERT GAUGE | KOC | 2000-10-25 | 82 |
| K994306 | REVERSO | KOC | 2000-03-20 | 90 |
| K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | FIE | 2000-01-06 | 302 |
| K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | FIB | 1998-11-25 | 84 |
| K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | KOC | 1997-08-18 | 90 |
| K963668 | MEDISYSTEMS PERITONEAL DIALYSIS SETS | KDJ | 1997-08-15 | 336 |
| K970536 | MEDISYSTEMS TRANDUCER PROTECTOR | FIB | 1997-05-12 | 89 |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | FJK | 1996-09-23 | 405 |
12 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-01-31.
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 Medisystems Corp.?
FDA lists 22 510(k) clearances under the applicant name “Medisystems Corp.” (first 1981, latest 2007), across 8 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 Medisystems Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medisystems Corp. is 90 days.
Which FDA product codes appear under Medisystems Corp.?
The most frequent FDA product codes under this applicant name are FIE (Needle, Fistula, 6); KOC (Accessories, Blood Circuit, Hemodialysis, 5); FIB (Protector, Transducer, Dialysis, 3).
Next steps
- See all 22 Medisystems Corp. clearances with predicates and recalls
- Run predicate analysis for product code FIE, Medisystems Corp.'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.