Sonicaid, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Sonicaid, Inc.” (first 1977, latest 1988), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 3 | 3 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | 2 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DQB | Phlebograph, Impedance | 1 | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 | 1 |
| HFO | Recorder, Pressure, Intrauterine | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Sonicaid, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873673 | BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL | DPT | 1988-02-26 | 168 |
| K872074 | 5 MHZ TRANSDUCER | JOP | 1987-08-25 | 88 |
| K863803 | VASOPULSE(TM)/MODEL 5000 | JOM | 1987-05-06 | 219 |
| K862720 | VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES | DPW | 1986-11-17 | 123 |
| K861237 | VASOVIEW DUPLEX IMAGING SYSTEM | ITX | 1986-07-14 | 103 |
| K851102 | VASOSCREEN IMPEDANCE PLETHYSMOGRAPH | DQB | 1985-05-16 | 58 |
| K833902 | VASOSCAN | JOP | 1984-01-27 | 74 |
| K832374 | PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH | JOM | 1983-12-01 | 136 |
| K833488 | SONICOMP | HEM | 1983-11-28 | 52 |
| K833227 | SONICAID MODEL D206E AIR EMBOLI-DETECT | LBA | 1983-10-27 | 72 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sonicaid, 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 Sonicaid, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Sonicaid, Inc.” (first 1977, latest 1988), across 13 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 Sonicaid, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonicaid, Inc. is 66 days.
Which FDA product codes appear under Sonicaid, Inc.?
The most frequent FDA product codes under this applicant name are HGM (System, Monitoring, Perinatal, 3); JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, 2); JOP (Transducer, Ultrasonic, 2).
Next steps
- See all 18 Sonicaid, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Sonicaid, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.