Fiab Spa: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Fiab Spa” (first 2009, latest 2019), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 136 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 | 1 | 119 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 304 |
| 2019 | 1 | 57 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Fiab Spa took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- General Hospital (3)
- Cardiovascular (1)
- Neurology (1)
- Ophthalmic (1)
- General and Plastic Surgery (1)
Most recent Fiab Spa 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | FLL | 2019-10-10 | 57 |
| K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | FLL | 2018-11-08 | 304 |
| K123361 | ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM | FLL | 2013-02-27 | 119 |
| K103783 | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC | LDD | 2011-06-16 | 171 |
| K100333 | FIAB SPA, MODELS F7244, F7233, F7234, F7277 | GEI | 2010-06-21 | 136 |
| K083428 | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | HQP | 2009-09-01 | 286 |
| K091163 | PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST | GXY | 2009-07-22 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Fiab Spa.
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 Fiab Spa?
FDA lists 7 510(k) clearances under the applicant name “Fiab Spa” (first 2009, latest 2019), across 5 product codes in 5 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 Fiab Spa?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fiab Spa is 136 days.
Which FDA product codes appear under Fiab Spa?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 7 Fiab Spa clearances with predicates and recalls
- Run predicate analysis for product code FLL, Fiab Spa'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.