Medical Repackers Co.: FDA clearances and approvals
Medical Repackers Co. has 5 FDA 510(k) clearances (first 1988, latest 1989), across 4 product codes in 2 review panels. Median 510(k) review time: 88 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| DQR | Cannula, Catheter | 1 | 1 |
| DWJ | System, Thermal Regulating | 1 | 1 |
Review panels
- Anesthesiology (3)
- Cardiovascular (2)
Most recent Medical Repackers Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890575 | ACCUTHERM PTS-200 | DWJ | 1989-05-05 | 88 |
| K882977 | ASK-300 | DQR | 1989-01-05 | 174 |
| K881313 | IQK-200 | BTR | 1988-05-19 | 52 |
| K881429 | YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH. | CAZ | 1988-04-25 | 27 |
| K874674 | AIK-100 ANESTHESIA INDUCTION KIT/TRAY | CAZ | 1988-03-02 | 110 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Repackers Co..
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 Repackers Co. have?
Medical Repackers Co. has 5 FDA 510(k) clearances (first 1988, latest 1989), across 4 product codes in 2 review panels.
How long does FDA take to clear Medical Repackers Co.'s 510(k)s?
The median time from FDA receipt to decision across Medical Repackers Co.'s cleared 510(k)s is 88 days.
What devices does Medical Repackers Co. make?
Its most frequent FDA product codes are CAZ (Anesthesia Conduction Kit, 2); BTR (Tube, Tracheal (W/Wo Connector), 1); DQR (Cannula, Catheter, 1).
Has Medical Repackers Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Repackers Co. Related entities may recall under other names.
Next steps
- See all 5 Medical Repackers Co. clearances with predicates and recalls
- Run predicate analysis for product code CAZ, Medical Repackers Co.'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.