Medasonics, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Medasonics, Inc.” (first 1978, latest 1999), across 12 product codes in 4 review panels. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| DSF | Recorder, Paper Chart | 2 | 2 |
| DXQ | Blood Pressure Cuff | 2 | 2 |
| JAF | Monitor, Ultrasonic, Nonfetal | 2 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 2 |
| DRM | Compressor, Cardiac, External | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| IOL | Treadmill, Powered | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Medasonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991441 | CADENCE DOPPLER ULTRASOUND SYSTEM | KNG | 1999-12-28 | 246 |
| K962796 | NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM | IYN | 1997-01-21 | 187 |
| K961116 | FIRST BEAT/CARDIO BEAT/CALC | IYO | 1996-08-08 | 141 |
| K914862 | CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS | IYN | 1992-12-03 | 401 |
| K911453 | OBTRASOUND STETHOSCOPE FETAL CALC | KNG | 1991-06-20 | 78 |
| K882018 | MEDACORD PVL, PERSONAL VASCULAR LABORATORY | JAF | 1988-09-21 | 131 |
| K872292 | TRANSPECT TRANSCRANIAL DOPPLER | IYN | 1987-08-14 | 59 |
| K854734 | MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE | DRM | 1986-02-10 | 77 |
| K833588 | VASCULAR LABORATORY TREADMILL VT1 | IOL | 1983-11-14 | 33 |
| K837481 | BF24 DOPPLER MODEL P872 AND P874 | — | 1983-06-24 | 46 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medasonics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medasonics, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Medasonics, Inc.” (first 1978, latest 1999), across 12 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 Medasonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medasonics, Inc. is 59 days.
Which FDA product codes appear under Medasonics, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3); DSF (Recorder, Paper Chart, 2); DXQ (Blood Pressure Cuff, 2).
Next steps
- See all 19 Medasonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Medasonics, 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.