Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Seratronics, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
440 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955299 | DPS 4 DIALYZER PREPARATION SYSTEM | Seratronics, Inc. | 1996-10-21 | 336 | 0 |
| K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1996-04-18 | 1129 | 0 |
| K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1995-11-29 | 440 | 0 |
| K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES | Seratronics, Inc. | 1994-08-29 | 774 | 0 |
| K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1992-02-24 | 131 | 0 |
| K874573 | FRESENIUS PURISTERIL 340 (TM) | Seratronics, Inc. | 1988-04-25 | 172 | 0 |
| K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 | Seratronics, Inc. | 1988-02-19 | 84 | 1 |
| K870725 | FRESENIUS HEMOFLOW F6 AND F8 | Seratronics, Inc. | 1987-05-01 | 66 | 0 |
| K870724 | FRESENIUS HEMOFLOW F60 AND F80 | Seratronics, Inc. | 1987-04-01 | 36 | 0 |
| K864587 | FRESENIUS ULTRAFLUX AV400, AV600 | Seratronics, Inc. | 1987-03-03 | 102 | 0 |
| K864169 | FRESENIUS HEMOFLOW F50 & F70 | Seratronics, Inc. | 1986-11-06 | 13 | 0 |
| K860674 | DRS-4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1986-04-07 | 42 | 0 |
| K861106 | FRESENIUS HEMOFLOW F80 DIALYZER | Seratronics, Inc. | 1986-04-07 | 14 | 0 |
| K855001 | FRESENIUS HEMODIALYSIS MACHINE A1008 BSM | Seratronics, Inc. | 1986-01-21 | 39 | 0 |
| K853851 | FRESENIUS DISPOSABLE BLOOD LINES | Seratronics, Inc. | 1985-11-12 | 57 | 0 |
| K852251 | FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40 | Seratronics, Inc. | 1985-07-25 | 63 | 0 |
| K844750 | FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD | Seratronics, Inc. | 1985-02-15 | 71 | 0 |
| K844641 | FRESENIUS HAEMODIALYSIS ;MACHINE A1008 | Seratronics, Inc. | 1985-02-14 | 78 | 0 |
| K843014 | FRESENIUS HAEMODIALYSIS A2008 | Seratronics, Inc. | 1984-10-18 | 79 | 0 |
| K832230 | DIALYZER PREPARATION SYS DPS-4 | Seratronics, Inc. | 1983-10-14 | 95 | 0 |
| K821863 | DIALYZER REPROCESSING SYSTEM DRS-4 | Seratronics, Inc. | 1982-10-18 | 116 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda