Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amicon, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
126 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930168 | CENTRICON -50 CONCENTRATOR | Amicon, Inc. | 1993-08-05 | 204 | 0 |
| K902837 | AMICON DIAFILTER 30 HEMOCONCENTRATOR | Amicon, Inc. | 1990-11-01 | 126 | 0 |
| K901286 | AMICON HEMOCONCENTRATOR SET | Amicon, Inc. | 1990-05-18 | 59 | 0 |
| K900280 | CENTRIPREP 100 | Amicon, Inc. | 1990-02-16 | 29 | 0 |
| K895405 | AMICON MINIFILTER PLUS HEMOFILTER | Amicon, Inc. | 1990-01-11 | 126 | 0 |
| K893733 | CENTRICON CONCENTRATOR | Amicon, Inc. | 1989-07-20 | 64 | 0 |
| K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | Amicon, Inc. | 1989-06-13 | 62 | 0 |
| K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM | Amicon, Inc. | 1988-02-19 | 66 | 0 |
| K870690 | CENTRIPREP CONCENTRATOR | Amicon, Inc. | 1987-03-19 | 28 | 0 |
| K863823 | AMICON DIAFILTER HEMOFILTER | Amicon, Inc. | 1986-11-06 | 37 | 0 |
| K853510 | MINIFILTER HEMOFILTER | Amicon, Inc. | 1985-09-12 | 22 | 0 |
| K833919 | CENTRICON MICRO-CONCENTRATOR | Amicon, Inc. | 1984-01-30 | 77 | 0 |
| K823881 | ARTERIOVENOUS BLOOD TUBING SET FOR | Amicon, Inc. | 1983-01-17 | 21 | 0 |
| K823288 | AMICON DIAFILTERS 20 & 30 HEMOFILTERS | Amicon, Inc. | 1982-12-16 | 42 | 0 |
| K813591 | HEMOFILTERS | Amicon, Inc. | 1982-03-31 | 93 | 0 |
| K820455 | CENTRIFREE MICROPARTITION SYSTEM | Amicon, Inc. | 1982-03-15 | 24 | 0 |
| K810810 | AMICON ULTRAFILTRATION MEMBRANES CMII | Amicon, Inc. | 1981-04-17 | 24 | 0 |
| K770398 | MINICON | Amicon, Inc. | 1977-04-06 | 35 | 0 |
| K761100 | MULTI-CELL ULTRAFILTRATION SYSTEM | Amicon, Inc. | 1976-12-06 | 13 | 0 |
| K760592 | MINICON CONCENTRATOR | Amicon, Inc. | 1976-11-23 | 77 | 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