Dynatech/Nevada, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dynatech/Nevada, Inc.” (first 1990, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 1 | 1 |
| DRL | Tester, Defibrillator | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
Review panels
- Cardiovascular (5)
- General Hospital (1)
Most recent Dynatech/Nevada, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942546 | CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER | DXN | 1995-01-27 | 241 |
| K935817 | MEDSIM 300 PATIENT SIMULATOR | DRT | 1994-01-18 | 47 |
| K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER | DRL | 1993-11-23 | 84 |
| K897074 | MODEL 215M PATIENT SIMULATOR | DSI | 1990-05-17 | 146 |
| K897029 | MODEL ECG100 SIMULATOR | DPS | 1990-04-26 | 129 |
| K897096 | MODEL 404A I.V. INFUSION PUMP ANALYZER | FRN | 1990-03-15 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Dynatech/Nevada, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Dynatech/Nevada, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dynatech/Nevada, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Dynatech/Nevada, Inc.” (first 1990, latest 1995), across 6 product codes in 2 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 Dynatech/Nevada, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynatech/Nevada, Inc. is 106 days.
Which FDA product codes appear under Dynatech/Nevada, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 1); DRL (Tester, Defibrillator, 1); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 6 Dynatech/Nevada, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Dynatech/Nevada, Inc.'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.