Smv America: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Smv America” (first 1997, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 7 | 7 |
Review panels
- Radiology (7)
Most recent Smv America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010509 | CEDARS-SINAI BPGS AND MOCO | KPS | 2001-04-27 | 65 |
| K003358 | QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) | KPS | 2001-01-19 | 85 |
| K002553 | DS DS I-SERIES | KPS | 2000-09-15 | 29 |
| K001681 | POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM | KPS | 2000-08-25 | 85 |
| K991565 | TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S | KPS | 1999-08-02 | 89 |
| K972686 | VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER | KPS | 1997-10-14 | 89 |
| K963273 | VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION | KPS | 1997-03-11 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Smv America.
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 Smv America?
FDA lists 7 510(k) clearances under the applicant name “Smv America” (first 1997, latest 2001), across 1 product code 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 Smv America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smv America is 85 days.
Which FDA product codes appear under Smv America?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 7).
Next steps
- See all 7 Smv America clearances with predicates and recalls
- Run predicate analysis for product code KPS, Smv America'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.