General Medical Merate S.P.A: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “General Medical Merate S.P.A” (first 1982, latest 2021), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 | 1 | 224 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 203 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 33 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name General Medical Merate S.P.A took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| OWB | Interventional Fluoroscopic X-Ray System | 2 | 2 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (6)
Most recent General Medical Merate S.P.A 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213081 | CLISIS SYSTEMS, Discovery RF180 | IZF | 2021-10-26 | 33 |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | JAA | 2018-05-21 | 203 |
| K140380 | OPERA SWING | JAA | 2014-09-26 | 224 |
| K082243 | PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS | OWB | 2008-11-07 | 92 |
| K041605 | PRECISION RXI ANALOG X-RAY SYSTEM | OWB | 2004-06-30 | 15 |
| K881386 | X-RAY GENERATING SYSTEM TF 1000 | IZO | 1988-07-08 | 98 |
| K827993 | MTH C/A MOBILE C ARM | — | 1982-09-13 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named General Medical Merate S.P.A.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- General Electric Co. (256 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Medical Merate S.P.A?
FDA lists 7 510(k) clearances under the applicant name “General Medical Merate S.P.A” (first 1982, latest 2021), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by General Medical Merate S.P.A?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Medical Merate S.P.A is 92 days.
Which FDA product codes appear under General Medical Merate S.P.A?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 2); OWB (Interventional Fluoroscopic X-Ray System, 2); IZF (System, X-Ray, Tomographic, 1).
Next steps
- See all 7 General Medical Merate S.P.A clearances with predicates and recalls
- Run predicate analysis for product code JAA, General Medical Merate S.P.A'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.