Medical, Inc.: FDA clearances and approvals
Medical, Inc. has 21 FDA 510(k) clearances (first 1977, latest 1993), across 9 product codes in 4 review panels. Median 510(k) review time: 22 days.
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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 4 | 4 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 4 | 4 |
| FJG | Dialyzer, Parallel Flow | 3 | 3 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 3 | 3 |
| CAK | Microfilter, Blood Transfusion | 2 | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 2 |
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| FPB | Filter, Infusion Line | 1 | 1 |
Review panels
Most recent Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926454 | ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON | CAI | 1993-06-22 | 180 |
| K894839 | OS-1 OCCLUSION SYSTEM - 1 | BZC | 1989-10-24 | 85 |
| K872001 | MODEL TPC-1A OXYGEN ANALYZER | CCL | 1987-06-15 | 20 |
| K863806 | MODEL A-1 OXYGEN ANALYZER | CCL | 1986-10-15 | 15 |
| K862609 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 | DTM | 1986-09-04 | 58 |
| K862591 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 | DTM | 1986-09-04 | 59 |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | KRJ | 1986-06-02 | 62 |
| K851370 | INTERFACE TRANSFUSION BLOOD FILTER #35 | CAK | 1985-06-27 | 83 |
| K823261 | INTERFACE TRANSFUSION BLOOD FILTER #30 | CAK | 1983-01-07 | 66 |
| K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | JOD | 1982-11-24 | 22 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical, Inc..
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 Medical, Inc. have?
Medical, Inc. has 21 FDA 510(k) clearances (first 1977, latest 1993), across 9 product codes in 4 review panels.
How long does FDA take to clear Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medical, Inc.'s cleared 510(k)s is 22 days.
What devices does Medical, Inc. make?
Its most frequent FDA product codes are DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 4); JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass, 4); FJG (Dialyzer, Parallel Flow, 3).
Has Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical, Inc. Related entities may recall under other names.
Next steps
- See all 21 Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTM, Medical, 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.