Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smv America · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
203 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010509 | CEDARS-SINAI BPGS AND MOCO | Smv America | 2001-04-27 | 65 | 0 |
| K003358 | QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED | Smv America | 2001-01-19 | 85 | 0 |
| K002553 | DS DS I-SERIES | Smv America | 2000-09-15 | 29 | 1 |
| K001681 | POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM | Smv America | 2000-08-25 | 85 | 0 |
| K991565 | TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL G | Smv America | 1999-08-02 | 89 | 0 |
| K972686 | VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION P | Smv America | 1997-10-14 | 89 | 0 |
| K963273 | VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION | Smv America | 1997-03-11 | 203 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda