Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inter-Med, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
229 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | 2026-04-15 | 197 | 0 |
| K241489 | ReminGel | Inter-Med, Inc. | 2025-01-08 | 229 | 0 |
| K241457 | Vista BC Putty | Inter-Med, Inc. | 2024-08-28 | 97 | 0 |
| K241354 | Sealer Solvent | Inter-Med, Inc. | 2024-08-27 | 106 | 0 |
| K221811 | Vista BC Sealer | Inter-Med, Inc. | 2022-11-21 | 152 | 0 |
| K211721 | PS System | Inter-Med, Inc. | 2021-12-02 | 181 | 0 |
| K112250 | CHX=CHX PLUS | Inter-Med, Inc. | 2011-10-28 | 85 | 0 |
| K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGEN | Inter-Med, Inc. | 2009-04-03 | 219 | 7 |
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