Filtertek, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Filtertek, Inc.” (first 1989, latest 1998), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | 5 | 5 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| FPB | Filter, Infusion Line | 2 | 2 |
Review panels
Most recent Filtertek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981548 | NFC NEEDLEFREE CONNECTOR MODEL 69900 | FPA | 1998-06-18 | 49 |
| K981547 | NFC NEEDLEFREE Y-SITE, MODEL 69970 | FPA | 1998-06-18 | 49 |
| K914792 | PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET | FPA | 1992-01-15 | 84 |
| K912848 | I.V. FILTER EXTENSION SET | FPB | 1991-11-29 | 154 |
| K912394 | TRANSDUCER PROTECTOR | FIB | 1991-08-30 | 94 |
| K911451 | I.V. EXTENDER SET | FPB | 1991-06-06 | 64 |
| K904912 | TRANSDUCER PROTECTOR | FIB | 1991-01-04 | 65 |
| K901409 | TRANSDUCER PROTECTOR | FIB | 1990-07-27 | 123 |
| K901996 | FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR | FIB | 1990-06-01 | 30 |
| K895281 | TRANSDUCER PROTECTOR | FIB | 1989-11-08 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Filtertek, 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 Filtertek, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Filtertek, Inc.” (first 1989, latest 1998), 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 Filtertek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Filtertek, Inc. is 70 days.
Which FDA product codes appear under Filtertek, Inc.?
The most frequent FDA product codes under this applicant name are FIB (Protector, Transducer, Dialysis, 5); FPA (Set, Administration, Intravascular, 3); FPB (Filter, Infusion Line, 2).
Next steps
- See all 10 Filtertek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FIB, Filtertek, 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.