Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IGG · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
25 daysmedian FDA review time
48 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882268 | ZINC FORMALIN CONCENTRATE | Anatech, Ltd. | 1988-06-15 | 15 | 0 |
| K861201 | FORMALDEHYDE SOLUTION, 37% | Surgipath Medical Industries, Inc. | 1986-04-11 | 11 | 0 |
| K811794 | 37% FORMALDEHYDE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K802506 | PLEASCENT OR FORMA-SCENT | Meridian Diagnostics, Inc. | 1980-11-12 | 28 | 0 |
| K792705 | PARA-PAK FORMALIN | Meridian Diagnostics, Inc. | 1980-01-21 | 25 | 1 |
| K792707 | PARA-PAK SAF | Meridian Diagnostics, Inc. | 1980-01-21 | 25 | 0 |
| K771201 | FORMALIN BUFFER CONCENTRATE | Central Labs. Assoc. MD Pathologists | 1977-08-22 | 48 | 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