Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZR — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
71 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844341 | UNITED SKIN BARRIER PASTE | Howmedica Corp. | 1985-01-18 | 71 | 0 |
| K803100 | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | E. R. Squibb & Sons, Inc. | 1981-01-08 | 30 | 0 |
| K791146 | COLO-TAPE | Suburban Ostomy Supply Co., Inc. | 1979-07-30 | 42 | 0 |
| K761340 | OSTOMY KARAYA GUM POWDER | Howmedica Corp. | 1977-03-07 | 69 | 0 |
| K770230 | KARAYA GUM POWDER | Atlantic Surgical | 1977-02-28 | 21 | 0 |
| K761319 | KARAYA GUM PRODUCTS - PROCESS CHANGE | Howmedica Corp. | 1977-02-15 | 50 | 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