FHC, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “FHC, Inc.” (first 2000, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 81 days. Since 2017 the median was 112 days, against 122 days for all cleared 510(k)s in the same product codes. 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 | 1 | 23 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 37 |
| 2019 | 0 | — |
| 2020 | 1 | 112 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 140 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name FHC, Inc. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 6 | 6 |
| GZL | Electrode, Depth | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| QRI | Surgical Planning Software For Neurological Stereotaxic Instruments | 1 | 1 |
Review panels
- Neurology (11)
- General and Plastic Surgery (1)
Most recent FHC, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231141 | STarFix Designer Software C0265 | QRI | 2023-09-08 | 140 |
| K200169 | VFS1 Bipolar Electrosurgical Generator | GEI | 2020-05-14 | 112 |
| K183123 | microTargeting Guideline 4000 5.0 System | GZL | 2018-12-20 | 37 |
| K121950 | MICROTARGETING XL STAR DRIVE SYSTEM | HAW | 2012-07-26 | 23 |
| K092192 | WAYPOINT STEREOTACTIC SYSTEM | HAW | 2010-02-12 | 206 |
| K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | HAW | 2009-09-18 | 29 |
| K071364 | MICROTARGETING GUIDELINE 4000 | GZL | 2007-07-25 | 70 |
| K033173 | MICRO TARGETING ELECTRODE | GZL | 2004-03-24 | 175 |
| K011775 | MICRO TARGETING DRIVE SYSTEM | HAW | 2001-08-30 | 84 |
| K011992 | FHC MICROTARGETING DRIVE SYSTEM | HAW | 2001-08-14 | 49 |
2 earlier clearances. See the full list in Caduvo.
Recalls
29 product recalls in 9 recall events; 1 initiated in the last five years. Most recent: 2024-10-04.
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 FHC, Inc.?
FDA lists 12 510(k) clearances under the applicant name “FHC, Inc.” (first 2000, latest 2023), across 4 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 FHC, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name FHC, Inc. is 81 days. Since 2017: 112 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under FHC, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 6); GZL (Electrode, Depth, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 12 FHC, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, FHC, 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.