Ics Medical Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ics Medical Corp.” (first 1987, latest 2003), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| GWN | Nystagmograph | 3 | 3 |
| KHH | Stimulator, Caloric-Air | 3 | 3 |
| EWO | Audiometer | 2 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 2 | 2 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 1 |
| LXV | Apparatus, Vestibular Analysis | 1 | 1 |
Review panels
- Ear, Nose and Throat (6)
- Neurology (6)
Most recent Ics Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031986 | ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS | EWO | 2003-07-24 | 27 |
| K013060 | ICS MEDICAL MODEL VG-30 VIDEO GOGGLES | GWN | 2001-12-10 | 90 |
| K011181 | ICS MEDICAL CHARTR OAE WITH TYMP | EWO | 2001-06-25 | 68 |
| K002985 | ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS | GWJ | 2000-12-13 | 79 |
| K991497 | ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM | GWN | 1999-07-28 | 90 |
| K972631 | ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER | GWN | 1997-09-22 | 70 |
| K960097 | CHARTR EP | GWJ | 1997-02-21 | 407 |
| K931609 | CHARTR ENG SYSTEM | GWM | 1995-09-26 | 908 |
| K931608 | NCA-200 | KHH | 1993-06-22 | 82 |
| K925237 | AUTOMATIC CALORIC IRRIGATION SYSTEM | KHH | 1993-05-05 | 201 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ics Medical 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ics Medical Corp.?
FDA lists 12 510(k) clearances under the applicant name “Ics Medical Corp.” (first 1987, latest 2003), 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 Ics Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ics Medical Corp. is 86 days.
Which FDA product codes appear under Ics Medical Corp.?
The most frequent FDA product codes under this applicant name are GWN (Nystagmograph, 3); KHH (Stimulator, Caloric-Air, 3); EWO (Audiometer, 2).
Next steps
- See all 12 Ics Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code GWN, Ics Medical 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.