Intl. Medical Devices , Ltd.: FDA clearances and approvals
Intl. Medical Devices , Ltd. has 12 FDA 510(k) clearances (first 1979, latest 1992), across 8 product codes in 4 review panels. Median 510(k) review time: 66 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 |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| GBX | Catheter, Irrigation | 2 | 2 |
| BWC | Needle, Emergency Airway | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| DRB | Stylet, Catheter | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| KGZ | Accessories, Catheter | 1 | 1 |
Review panels
Most recent Intl. Medical Devices , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913541 | NEO-THOR THORACOSTOMY KIT | FMF | 1992-04-09 | 244 |
| K913540 | PEDIA-THOR THORACOSTOMY KIT | FMF | 1992-04-09 | 244 |
| K913542 | THORACIC CATHETER WITH GUIDE | GBX | 1992-01-21 | 165 |
| K913539 | THORACIC CATHTER STYLET | GBX | 1992-01-21 | 165 |
| K913543 | THORACIC CATHETER STYLET | DRB | 1991-10-04 | 56 |
| K862909 | RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM | BTO | 1986-09-09 | 40 |
| K850398 | NU-CATH EMERGENCY KIT | FOZ | 1985-03-27 | 54 |
| K843785 | WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR | BTO | 1984-10-23 | 26 |
| K842666 | NU-THOR THORACOSTOMY KIT | KGZ | 1984-09-20 | 72 |
| K840925 | PEDIA-TRAKE CRICOTHYROTOMY KIT | BTO | 1984-05-02 | 61 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intl. Medical Devices , Ltd..
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 Intl. Medical Devices , Ltd. have?
Intl. Medical Devices , Ltd. has 12 FDA 510(k) clearances (first 1979, latest 1992), across 8 product codes in 4 review panels.
How long does FDA take to clear Intl. Medical Devices , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Intl. Medical Devices , Ltd.'s cleared 510(k)s is 66 days.
What devices does Intl. Medical Devices , Ltd. make?
Its most frequent FDA product codes are BTO (Tube, Tracheostomy (W/Wo Connector), 3); FMF (Syringe, Piston, 2); GBX (Catheter, Irrigation, 2).
Has Intl. Medical Devices , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Intl. Medical Devices , Ltd. Related entities may recall under other names.
Next steps
- See all 12 Intl. Medical Devices , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTO, Intl. Medical Devices , Ltd.'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.