Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cedars-Sinai Medical Center · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
385 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172609 | CSMC Cardiac Suite | Cedars-Sinai Medical Center | 2017-11-03 | 64 | 0 |
| K141652 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | Cedars-Sinai Medical Center | 2014-07-22 | 32 | 0 |
| K123433 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | Cedars-Sinai Medical Center | 2013-02-26 | 111 | 0 |
| K112474 | CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE | Cedars-Sinai Medical Center | 2011-09-23 | 28 | 0 |
| K100714 | CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODE | Cedars-Sinai Medical Center | 2011-04-01 | 385 | 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