Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FOB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
81 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K791346 | DISPOSABLE BEDPAN | General Clinical Plastics Corp. | 1979-08-03 | 22 | 0 |
| K780370 | STAND UP TOILET | Medical Specialty Products, Inc. | 1978-04-10 | 34 | 0 |
| K760490 | BEDPAN, GENERAL MEDICAL MEDI-PAK | Landmark Plastics | 1976-11-12 | 81 | 0 |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | Bemis Health Care | 1976-08-23 | 17 | 0 |
| K760307 | BEDPAN, SINGLE PATIENT USE, TECNOL | Tecnol New Jersey Wound Care, Inc. | 1976-08-11 | 16 | 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