Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MNV · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
348 daysmedian FDA review time
571 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101750 | RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z | Reprocessing Products Corp | 2011-01-07 | 199 | 0 |
| K031267 | STERICHEK BICARB PH REAGENT STRIPS | Environmental Test Systems, Inc. | 2003-12-23 | 246 | 0 |
| K936311 | MITEK MINI ANCHOR | Mitek Surgical Products, Inc. | 1995-10-31 | 559 | 0 |
| K941599 | MITEK ABSORBABLE ANCHOR | Mitek Surgical Products, Inc. | 1995-10-24 | 571 | 0 |
| K944051 | ABSORBALBE ANCHOR | Mitek Surgical Products, Inc. | 1995-08-02 | 348 | 0 |
| K945491 | SERIM(TM) BICARB PH REAGENT STRIPS | Serim Research Corp. | 1995-02-01 | 85 | 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