Millipore Corp.: FDA clearances and approvals
Millipore Corp. has 32 FDA 510(k) clearances (first 1977, latest 2010), plus 1 PMA decision, across 18 product codes in 7 review panels. Median 510(k) review time: 56 days. openFDA lists 8 product recalls by a recalling firm named Millipore Corp.
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 |
|---|---|---|---|
| LDM | Instrumentation, High Pressure Liquid Chromatography | 7 | 7 |
| BSN | Filter, Conduction, Anesthetic | 3 | 3 |
| JRL | Unit, Filter, Membrane | 3 | 3 |
| KIE | Apparatus, High Pressure Liquid Chromatography | 3 | 3 |
| FIP | Subsystem, Water Purification | 2 | 2 |
| FPB | Filter, Infusion Line | 2 | 2 |
| DPM | Columns, Liquid Chromatography | 1 | 1 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Toxicology (11)
- Gastroenterology and Urology (6)
- Clinical Chemistry (4)
- Anesthesiology (3)
- General Hospital (3)
- Microbiology (3)
- Immunology (1)
Most recent Millipore Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093815 | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 | OMG | 2010-03-12 | 88 |
| K081527 | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | GQL | 2009-04-01 | 303 |
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | BSN | 2003-01-17 | 56 |
| K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | BSN | 2002-04-04 | 121 |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | BSN | 1997-06-10 | 267 |
| K941326 | ULTRAFREE-CL | JJH | 1994-05-27 | 70 |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | FIB | 1994-04-21 | 244 |
| K924347 | WATERS(TM) 996 PDA | KIE | 1992-12-11 | 106 |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | LDM | 1992-09-11 | 114 |
| K920136 | WATERS 717 AUTOSAMPLER | LDM | 1992-02-19 | 37 |
22 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850092 | PMA | THERAPEUTIC APHERESIS SYSTEM | 1986-11-18 |
Recalls
8 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2009-11-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Millipore Corp. have?
Millipore Corp. has 32 FDA 510(k) clearances (first 1977, latest 2010), plus 1 PMA decision, across 18 product codes in 7 review panels.
How long does FDA take to clear Millipore Corp.'s 510(k)s?
The median time from FDA receipt to decision across Millipore Corp.'s cleared 510(k)s is 56 days.
What devices does Millipore Corp. make?
Its most frequent FDA product codes are LDM (Instrumentation, High Pressure Liquid Chromatography, 7); BSN (Filter, Conduction, Anesthetic, 3); JRL (Unit, Filter, Membrane, 3).
Has Millipore Corp. had device recalls?
openFDA lists 8 product recalls in 3 recall events by a recalling firm whose name matches Millipore Corp; the most recent began 2009-11-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 32 Millipore Corp. clearances with predicates and recalls
- Run predicate analysis for product code LDM, Millipore Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.