Quality Electrodynamics, LLC: FDA clearances and approvals
Quality Electrodynamics, LLC has 34 FDA 510(k) clearances (first 2007, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 46 days. Since 2017 its median was 60 days, against 88 days for all cleared 510(k)s in the same product codes. openFDA lists 9 product recalls by a recalling firm named Quality Electrodynamics, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 28 |
| 2013 | 0 | — |
| 2014 | 3 | 56 |
| 2015 | 4 | 58 |
| 2016 | 5 | 37 |
| 2017 | 2 | 44 |
| 2018 | 3 | 29 |
| 2019 | 0 | — |
| 2020 | 2 | 46 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 60 |
| 2024 | 2 | 94 |
| 2025 | 2 | 138 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Quality Electrodynamics, LLC's cleared 510(k)s took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 33 | 33 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (34)
Most recent Quality Electrodynamics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | MOS | 2025-02-28 | 59 |
| K242006 | SureWave Elastography (Q7000225) | LNH | 2025-02-12 | 218 |
| K233652 | Contour Hand/Wrist (Q7000232) | MOS | 2024-02-16 | 94 |
| K233656 | Contour Shoulder | MOS | 2024-02-15 | 93 |
| K223429 | Contour Knee | MOS | 2023-01-13 | 60 |
| K200477 | Flex Body Speeder | MOS | 2020-04-08 | 41 |
| K193140 | Flex Body SPEEDER | MOS | 2020-01-03 | 51 |
| K183111 | Contour 24 | MOS | 2018-12-07 | 29 |
| K181697 | 16ch Foot/ Ankle SPEEDER | MOS | 2018-07-11 | 14 |
| K173469 | 16ch T/R Hand Wrist Coil | MOS | 2018-01-09 | 62 |
24 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-08-20.
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 Quality Electrodynamics, LLC's product codes (a text match, not an official crosswalk):
- 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)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Quality Electrodynamics, LLC have?
Quality Electrodynamics, LLC has 34 FDA 510(k) clearances (first 2007, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Quality Electrodynamics, LLC's 510(k)s?
The median time from FDA receipt to decision across Quality Electrodynamics, LLC's cleared 510(k)s is 46 days. Since 2017: 60 days, versus 88 days for all cleared 510(k)s in the same product codes.
What devices does Quality Electrodynamics, LLC make?
Its most frequent FDA product codes are MOS (Coil, Magnetic Resonance, Specialty, 33); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Has Quality Electrodynamics, LLC had device recalls?
openFDA lists 9 product recalls in 3 recall events by a recalling firm whose name matches Quality Electrodynamics, LLC; the most recent began 2019-08-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 34 Quality Electrodynamics, LLC clearances with predicates and recalls
- Run predicate analysis for product code MOS, Quality Electrodynamics, LLC'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.