Seratronics, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Seratronics, Inc.” (first 1982, latest 1996), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| LIF | Dialyzer Reprocessing System | 9 | 9 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 6 | 6 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 2 | 2 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 2 | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FLC | Station, Dialysis Control, Negative Pressure Type | 1 | 1 |
Review panels
Most recent Seratronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955299 | DPS 4 DIALYZER PREPARATION SYSTEM | LIF | 1996-10-21 | 336 |
| K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM | LIF | 1996-04-18 | 1129 |
| K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM | LIF | 1995-11-29 | 440 |
| K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES | LIF | 1994-08-29 | 774 |
| K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM | LIF | 1992-02-24 | 131 |
| K874573 | FRESENIUS PURISTERIL 340 (TM) | LIF | 1988-04-25 | 172 |
| K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 | FJI | 1988-02-19 | 84 |
| K870725 | FRESENIUS HEMOFLOW F6 AND F8 | FJI | 1987-05-01 | 66 |
| K870724 | FRESENIUS HEMOFLOW F60 AND F80 | KDI | 1987-04-01 | 36 |
| K864587 | FRESENIUS ULTRAFLUX AV400, AV600 | KDI | 1987-03-03 | 102 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Seratronics, 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 Seratronics, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Seratronics, Inc.” (first 1982, latest 1996), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Seratronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seratronics, Inc. is 79 days.
Which FDA product codes appear under Seratronics, Inc.?
The most frequent FDA product codes under this applicant name are LIF (Dialyzer Reprocessing System, 9); KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 6); FJI (Dialyzer, Capillary, Hollow Fiber, 2).
Next steps
- See all 21 Seratronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIF, Seratronics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.