Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shelhigh, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
177 daysmedian FDA review time
687 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032893 | SHELHIGH NO-REACT BIOCUFF | Shelhigh, Inc. | 2003-12-19 | 93 | 0 |
| K023940 | SHELHIGH BIORING | Shelhigh, Inc. | 2003-06-04 | 190 | 0 |
| K982101 | SHELHIGH NO-REACT DURA SHIELD | Shelhigh, Inc. | 2000-05-02 | 687 | 0 |
| K991567 | SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. | Shelhigh, Inc. | 1999-07-14 | 70 | 0 |
| K982810 | SHELHIGH NO-REACT VASCUPATCH | Shelhigh, Inc. | 1998-10-28 | 78 | 0 |
| K981756 | SHELHIGH NO-REACT PNEUMOPLEDGETS | Shelhigh, Inc. | 1998-08-05 | 79 | 0 |
| K974914 | SHELHIGH NO-REACT PERICARDIAL PATCHES | Shelhigh, Inc. | 1998-06-03 | 177 | 0 |
| K964467 | SHELHIGH PERICARDIAL PATCH | Shelhigh, Inc. | 1997-09-23 | 320 | 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