Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DSJ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
230 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019-10-27 | 230 | 3 |
| K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017-03-31 | 98 | 0 |
| K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015-09-29 | 92 | 0 |
| K133961 | SURESIGNS VS3, SURESIGNS VS4 | Philips Medical Systems | 2014-06-26 | 184 | 0 |
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | 3M Health Care, Sarns | 1996-06-04 | 90 | 1 |
| K910262 | KELLER VITAL SIGNS MONITOR - KMS-890 | Keller Medical Specialties Products, Inc. | 1991-04-01 | 69 | 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