Medrad, Inc.: FDA clearances and approvals
Medrad, Inc. has 105 FDA 510(k) clearances (first 1976, latest 2014), across 23 product codes in 5 review panels. Median 510(k) review time: 75 days. openFDA lists 29 product recalls by a recalling firm named Medrad, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 116 |
| 2013 | 2 | 98 |
| 2014 | 1 | 335 |
| 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 32 | 32 |
| MOS | Coil, Magnetic Resonance, Specialty | 18 | 18 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 16 | 16 |
| FRN | Pump, Infusion | 6 | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| MCW | Catheter, Peripheral, Atherectomy | 3 | 3 |
| QEZ | Aspiration Thrombectomy Catheter | 3 | 3 |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | 2 | 2 |
Plus 13 more product codes.
Review panels
- Radiology (45)
- General Hospital (42)
- Cardiovascular (15)
- Clinical Toxicology (2)
- General and Plastic Surgery (1)
Most recent Medrad, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | MCW | 2014-08-27 | 335 |
| K130381 | ANGIOJET ULTRA POWER PULSE KIT | QEW | 2013-07-29 | 165 |
| K130637 | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM | MCW | 2013-04-10 | 30 |
| K122916 | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM | MCW | 2012-10-19 | 28 |
| K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | QEZ | 2012-06-06 | 204 |
| K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE | DXT | 2011-12-15 | 52 |
| K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET | QEZ | 2011-12-02 | 11 |
| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | DXT | 2011-10-14 | 85 |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | QEZ | 2011-05-24 | 27 |
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | FRN | 2010-06-23 | 93 |
95 earlier clearances. See the full list in Caduvo.
Recalls
29 product recalls in 17 recall events; 0 initiated in the last five years. Most recent: 2013-04-15.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medrad, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Medrad, Inc. have?
Medrad, Inc. has 105 FDA 510(k) clearances (first 1976, latest 2014), across 23 product codes in 5 review panels.
How long does FDA take to clear Medrad, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medrad, Inc.'s cleared 510(k)s is 75 days.
What devices does Medrad, Inc. make?
Its most frequent FDA product codes are DXT (Injector And Syringe, Angiographic, 32); MOS (Coil, Magnetic Resonance, Specialty, 18); LNH (System, Nuclear Magnetic Resonance Imaging, 16).
Has Medrad, Inc. had device recalls?
openFDA lists 29 product recalls in 17 recall events by a recalling firm whose name matches Medrad, Inc; the most recent began 2013-04-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 105 Medrad, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Medrad, 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.