Millar Instruments, Inc.: FDA clearances and approvals
Millar Instruments, Inc. has 18 FDA 510(k) clearances (first 1979, latest 2011), across 8 product codes in 1 review panel. Median 510(k) review time: 90 days. openFDA lists 3 product recalls by a recalling firm named Millar Instruments, Inc.
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 |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | 7 | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | 2 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DXW | System, Phonocatheter, Intracavitary | 1 | 1 |
| KRB | Probe, Thermodilution | 1 | 1 |
Review panels
- Cardiovascular (18)
Most recent Millar Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112323 | CARDIA-CATH | DXO | 2011-10-18 | 67 |
| K093111 | MIKRO-CATH, MODEL 825-0101 | DXO | 2010-01-05 | 96 |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | DRQ | 2002-07-02 | 280 |
| K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER | DQO | 2000-03-01 | 120 |
| K952773 | MIKRO-TIP ANGIOGRAPHIC CATHETER | DQO | 1995-11-07 | 144 |
| K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER | DXO | 1994-08-05 | 282 |
| K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN | DXO | 1992-04-20 | 118 |
| K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER | JOP | 1990-01-24 | 85 |
| K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER | DXO | 1989-12-07 | 73 |
| K883651 | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER | DQO | 1988-11-18 | 84 |
8 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2011-03-08.
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 Millar Instruments, Inc. have?
Millar Instruments, Inc. has 18 FDA 510(k) clearances (first 1979, latest 2011), across 8 product codes in 1 review panel.
How long does FDA take to clear Millar Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Millar Instruments, Inc.'s cleared 510(k)s is 90 days.
What devices does Millar Instruments, Inc. make?
Its most frequent FDA product codes are DXO (Transducer, Pressure, Catheter Tip, 7); DQO (Catheter, Intravascular, Diagnostic, 3); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 2).
Has Millar Instruments, Inc. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Millar Instruments, Inc; the most recent began 2011-03-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 18 Millar Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXO, Millar Instruments, Inc.'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.