Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Millipore Corp. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
121 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | Millipore Corp. | 2003-01-17 | 56 | 1 |
| K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | Millipore Corp. | 2002-04-04 | 121 | 0 |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | Millipore Corp. | 1997-06-10 | 267 | 0 |
| K941326 | ULTRAFREE-CL | Millipore Corp. | 1994-05-27 | 70 | 0 |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | Millipore Corp. | 1994-04-21 | 244 | 0 |
| K924347 | WATERS(TM) 996 PDA | Millipore Corp. | 1992-12-11 | 106 | 0 |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | Millipore Corp. | 1992-09-11 | 114 | 0 |
| K920136 | WATERS 717 AUTOSAMPLER | Millipore Corp. | 1992-02-19 | 37 | 0 |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | Millipore Corp. | 1991-12-10 | 46 | 0 |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Millipore Corp. | 1990-09-11 | 33 | 0 |
| K872792 | WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM | Millipore Corp. | 1987-07-31 | 17 | 0 |
| K872582 | HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM | Millipore Corp. | 1987-07-16 | 16 | 0 |
| K870949 | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM | Millipore Corp. | 1987-04-22 | 43 | 0 |
| K864267 | SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) | Millipore Corp. | 1987-01-09 | 72 | 0 |
| K862506 | THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR | Millipore Corp. | 1986-07-29 | 28 | 0 |
| K850272 | WATERS 740 DATA MODULE-PLOTTER INTEGRATOR | Millipore Corp. | 1985-03-06 | 42 | 0 |
| K850359 | WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D | Millipore Corp. | 1985-03-05 | 34 | 0 |
| K841403 | HEMO-RO WATER PURIFICATION SYS | Millipore Corp. | 1984-07-06 | 94 | 0 |
| K832952 | MILLIPORE IVEX INT FILTER UNIT | Millipore Corp. | 1983-10-04 | 36 | 0 |
| K811432 | MILLIPORE DUAL RATE INTRAVENOUS CASSETTE | Millipore Corp. | 1981-07-13 | 52 | 0 |
| K803275 | KPP PERITONEAL DIALYSATE FILTER | Millipore Corp. | 1981-03-13 | 74 | 0 |
| K801500 | ULTRAFREE CALCIUM FILTER | Millipore Corp. | 1980-08-20 | 54 | 0 |
| K790445 | ULTRA-FREE | Millipore Corp. | 1979-06-28 | 115 | 0 |
| K781043 | CEA-IMMERSIBLE SEPARATOR | Millipore Corp. | 1978-09-15 | 87 | 0 |
| K780352 | IMMUNOZYME TOXOPLASMA ANTIBODY | Millipore Corp. | 1978-06-28 | 117 | 0 |
| K780114 | IMMUNOZYME E. HISTOLYTICA ANTIGENS | Millipore Corp. | 1978-04-19 | 86 | 0 |
| K772236 | FILTER, PERITONEAL DIALY. ADMIN. SET | Millipore Corp. | 1978-01-24 | 48 | 0 |
| K771763 | HEMO-RO | Millipore Corp. | 1977-10-04 | 15 | 0 |
| K770703 | FILTER UNIT, SINGLE USE | Millipore Corp. | 1977-06-14 | 57 | 0 |
| K770150 | ELECTRO IMMUNO ASSAY KIT | Millipore Corp. | 1977-02-01 | 8 | 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