Concord Laboratories, Inc.: FDA clearances and approvals
Concord Laboratories, Inc. has 42 FDA 510(k) clearances (first 1976, latest 1989), across 18 product codes in 6 review panels. Median 510(k) review time: 40 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 6 | 6 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 5 | 5 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 | 5 |
| CBT | Arterial Blood Sampling Kit | 4 | 4 |
| BSY | Catheters, Suction, Tracheobronchial | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 3 | 3 |
| LKB | Pad, Alcohol, Device Disinfectant | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| FMC | Patient Examination Glove | 1 | 1 |
Plus 8 more product codes.
Review panels
- General Hospital (13)
- Anesthesiology (11)
- Gastroenterology and Urology (11)
- General and Plastic Surgery (2)
- Clinical Chemistry (1)
- Microbiology (1)
Most recent Concord Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT | LKB | 1989-05-16 | 246 |
| K871825 | MECONIUM SUCTION CATHETER | BSY | 1987-06-29 | 49 |
| K864535 | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 | BSY | 1987-01-06 | 50 |
| K862039 | CONCORD CARE TRAY | — | 1986-07-03 | 36 |
| K854601 | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH | BSO | 1986-01-10 | 53 |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | GCB | 1985-11-13 | 16 |
| K851134 | REGIONAL ANESTHESIA TRAYS | CAZ | 1985-07-15 | 116 |
| K842095 | EPIDURAL TRAYS | CAZ | 1984-07-03 | 39 |
| K841486 | ARTERIAL BLOOD SAMPLING KITS | CBT | 1984-05-23 | 43 |
| K840987 | VAPORIZED HEPARIN | CBT | 1984-04-05 | 29 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Concord Laboratories, 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 Concord Laboratories, Inc. have?
Concord Laboratories, Inc. has 42 FDA 510(k) clearances (first 1976, latest 1989), across 18 product codes in 6 review panels.
How long does FDA take to clear Concord Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Concord Laboratories, Inc.'s cleared 510(k)s is 40 days.
What devices does Concord Laboratories, Inc. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 6); FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 5); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 5).
Has Concord Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Concord Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 42 Concord Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Concord Laboratories, 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.