Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRT · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
270 daysmedian FDA review time
528 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002937 | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | Albert Browne , Ltd. | 2001-11-05 | 410 | 0 |
| K965154 | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | Albert Browne , Ltd. | 1997-09-19 | 270 | 0 |
| K951113 | CROSS-CHECKS | Steritec Products Mfg Co, Inc. | 1996-08-19 | 528 | 0 |
| K951703 | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICAT | Products For Medicine | 1995-06-28 | 77 | 0 |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | Propper Mfg. Co., Inc. | 1987-06-01 | 34 | 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