Concord/Portex: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Concord/Portex” (first 1989, latest 1993), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under ICU Medical, based on public ownership records.
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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 3 | 3 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 | 3 |
| CBT | Arterial Blood Sampling Kit | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BYO | Bottle, Blow | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
Plus 4 more product codes.
Review panels
- Anesthesiology (14)
- General Hospital (4)
- Clinical Chemistry (3)
- Dental (1)
- Obstetrics and Gynecology (1)
Most recent Concord/Portex 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923559 | STERI-CATH MDI | CAF | 1993-10-25 | 465 |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | MAJ | 1993-07-27 | 193 |
| K924541 | EPIDURAL MINIPACK | BYO | 1993-07-09 | 304 |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | CBT | 1993-06-22 | 152 |
| K923127 | NEEDLE-PRO CARTRIDGE | FMI | 1993-04-29 | 307 |
| K923910 | HEAT MOISTURE CONDENSER | BYD | 1993-01-26 | 175 |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | BTO | 1992-09-02 | 86 |
| K922445 | VACU-PRO | JKA | 1992-08-12 | 82 |
| K915452 | ANESTHESIA BREATHING CIRCUIT | CAI | 1992-02-14 | 71 |
| K911809 | NEW-VENT | JKA | 1991-08-26 | 125 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Concord/Portex.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Concord/Portex (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Concord/Portex?
FDA lists 23 510(k) clearances under the applicant name “Concord/Portex” (first 1989, latest 1993), across 14 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Concord/Portex?
The median time from FDA receipt to decision across 510(k)s cleared under the name Concord/Portex is 86 days.
Which FDA product codes appear under Concord/Portex?
The most frequent FDA product codes under this applicant name are BSY (Catheters, Suction, Tracheobronchial, 3); BTO (Tube, Tracheostomy (W/Wo Connector), 3); FMI (Needle, Hypodermic, Single Lumen, 3).
Next steps
- See all 23 Concord/Portex clearances with predicates and recalls
- Run predicate analysis for product code BSY, Concord/Portex's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.