Del Mar Avionics: FDA filings under this applicant name
FDA lists 54 510(k) clearances under the applicant name “Del Mar Avionics” (first 1977, latest 1999), across 19 product codes in 4 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 15 | 15 |
| DSI | Detector And Alarm, Arrhythmia | 10 | 10 |
| GWQ | Full-Montage Standard Electroencephalograph | 7 | 7 |
| DPS | Electrocardiograph | 3 | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 2 |
| DXK | Echocardiograph | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
Plus 9 more product codes.
Review panels
- Cardiovascular (40)
- Neurology (9)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
Most recent Del Mar Avionics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990027 | OMNICORDER, MODEL 464 | DSH | 1999-02-09 | 35 |
| K971696 | SENTINEL RECORDER, MODELS 471/472 | DXH | 1997-12-30 | 236 |
| K963174 | HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) | DSH | 1997-03-13 | 211 |
| K950020 | HOLTER PACERCORDER(R) | DSH | 1995-08-17 | 225 |
| K942653 | HOLTER SSR DIGICORDER(TM) | DSH | 1995-05-10 | 341 |
| K922221 | SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM | LOS | 1993-04-21 | 344 |
| K896862 | MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM | DSI | 1990-04-18 | 133 |
| K895793 | MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION | DSH | 1990-02-13 | 138 |
| K894543 | MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER | DSI | 1990-02-08 | 203 |
| K891148 | MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM | DSI | 1989-05-11 | 69 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Del Mar Avionics.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Del Mar Avionics?
FDA lists 54 510(k) clearances under the applicant name “Del Mar Avionics” (first 1977, latest 1999), across 19 product codes in 4 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 Del Mar Avionics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Del Mar Avionics is 71 days.
Which FDA product codes appear under Del Mar Avionics?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 15); DSI (Detector And Alarm, Arrhythmia, 10); GWQ (Full-Montage Standard Electroencephalograph, 7).
Next steps
- See all 54 Del Mar Avionics clearances with predicates and recalls
- Run predicate analysis for product code DSH, Del Mar Avionics'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.