Dynarex Corp.: FDA clearances and approvals
Dynarex Corp. has 27 FDA 510(k) clearances (first 1986, latest 2018), across 21 product codes in 7 review panels. Median 510(k) review time: 100 days. openFDA lists 6 product recalls by a recalling firm named Dynarex Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 82 |
| 2016 | 1 | 361 |
| 2017 | 0 | — |
| 2018 | 1 | 230 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dynarex Corp.'s cleared 510(k)s took a median 230 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 4 | 4 |
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KMF | Bandage, Liquid | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| EZD | Catheter, Straight | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| HFW | Clamp, Umbilical | 1 | 1 |
Plus 11 more product codes.
Review panels
- General and Plastic Surgery (10)
- General Hospital (7)
- Anesthesiology (4)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
- Ophthalmic (1)
- Radiology (1)
Most recent Dynarex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172266 | Dynarex Three-Way Stopcock | FMG | 2018-03-14 | 230 |
| K152970 | Dynarex Xeroform Petrolatum Dressing | FRO | 2016-10-03 | 361 |
| K151575 | Dynarex Eye Cups | LXQ | 2015-09-01 | 82 |
| K103086 | DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC | EZD | 2011-06-07 | 231 |
| K102637 | DYNAREX ULTRASOUND GEL | MUI | 2011-02-16 | 155 |
| K092488 | DYNAREX STERILE LUBRICATING JELLY | KMJ | 2009-12-18 | 127 |
| K082863 | DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) | KNT | 2009-01-09 | 102 |
| K081569 | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2008-09-12 | 100 |
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | CBP | 2005-12-22 | 83 |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | HIB | 2005-11-09 | 76 |
17 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2018-05-08.
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 Dynarex Corp. have?
Dynarex Corp. has 27 FDA 510(k) clearances (first 1986, latest 2018), across 21 product codes in 7 review panels.
How long does FDA take to clear Dynarex Corp.'s 510(k)s?
The median time from FDA receipt to decision across Dynarex Corp.'s cleared 510(k)s is 100 days.
What devices does Dynarex Corp. make?
Its most frequent FDA product codes are EFQ (Gauze/Sponge, Internal, 4); FRO (Dressing, Wound, Drug, 3); KMF (Bandage, Liquid, 2).
Has Dynarex Corp. had device recalls?
openFDA lists 6 product recalls in 5 recall events by a recalling firm whose name matches Dynarex Corp; the most recent began 2018-05-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 27 Dynarex Corp. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Dynarex Corp.'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.