Engineering Dynamics Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Engineering Dynamics Corp.” (first 1979, latest 1987), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 39 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| ISD | Exerciser, Measuring | 2 | 2 |
| IYX | Camera, Scintillation (Gamma) | 2 | 2 |
| FPO | Stretcher, Wheeled | 1 | 1 |
| GZO | Device, Galvanic Skin Response Measurement | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (3)
- Cardiovascular (2)
- Physical Medicine (2)
- General Hospital (1)
- Neurology (1)
Most recent Engineering Dynamics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871494 | UPPERCYCLE STATIONARY EXERCISE MACHINES | ISD | 1987-05-06 | 20 |
| K844578 | NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA | FPO | 1985-05-14 | 172 |
| K842108 | UNIVERSAL EXAMINATION TABLE | GZO | 1984-07-17 | 49 |
| K834098 | STATIONARY EXERCISE BICYCLE | ISD | 1983-12-27 | 29 |
| K828313 | DIGITAL RADIOGRAPHY EXAMINATION TABLE | — | 1982-10-07 | 15 |
| K802254 | GENERAL ULTRASOUND EXAM. TABLE | IYN | 1980-11-26 | 71 |
| K790545 | STRESS TESTING SYSTEM, LATERAL TILTING | DRT | 1979-06-06 | 78 |
| K790544 | STRESS TESTING SYSTEM, MULTI-POSITION | DRT | 1979-06-05 | 75 |
| K790466 | U-MAT | IYX | 1979-03-28 | 23 |
| K790499 | MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER | IYX | 1979-03-26 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Engineering Dynamics Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Engineering, Inc. (5 510(k)s)
- Engineering Consulting Services, Inc. (1 510(k)s)
- Engineering Controls For Medicine (1 510(k)s)
- Engineering Developments, Co. (1 510(k)s)
- Engineering Mechanics, Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Engineering Dynamics Corp.?
FDA lists 10 510(k) clearances under the applicant name “Engineering Dynamics Corp.” (first 1979, latest 1987), across 7 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 Engineering Dynamics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Engineering Dynamics Corp. is 39 days.
Which FDA product codes appear under Engineering Dynamics Corp.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 2); ISD (Exerciser, Measuring, 2); IYX (Camera, Scintillation (Gamma), 2).
Next steps
- See all 10 Engineering Dynamics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Engineering Dynamics Corp.'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.