Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MSR · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993361 | TUBING EXTENSION SET | Hurricane Medical | 2000-01-04 | 90 | 0 |
| K983448 | ML UNIVERSAL TUBING | Med-Logics, Inc. | 1998-12-18 | 79 | 0 |
| K980849 | SURGIN KIT | Surgin Surgical Instrumentation, Inc. | 1998-07-09 | 154 | 0 |
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DA | Storz Instrument Co. | 1998-06-01 | 140 | 0 |
| K972522 | ML-DISPOSABLE PAK | Med-Logics, Inc. | 1997-09-30 | 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