Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ORC · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
293 daysmedian FDA review time
616 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190027 | SteriStay | Toul Meditech AB | 2019-05-10 | 123 | 0 |
| K173349 | Operio | Toul Meditech AB | 2017-12-20 | 56 | 0 |
| K163455 | SurgiCube | Surgicube International B.V. | 2017-09-28 | 293 | 0 |
| K153498 | Operio | Toul Meditech AB | 2016-07-20 | 226 | 0 |
| K123006 | AIR BARRIER SYSTEM (ABS) | Nimbic Systems, Inc. | 2013-12-20 | 449 | 0 |
| K092801 | ABS BLOWER, ABS NOZZLE, MODEL 1001 | Nimbic Systems, LLC | 2011-05-20 | 616 | 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