Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Biomaterials Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
296 daysmedian FDA review time
776 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922455 | EVERT-O-CATH CATHETER | American Biomaterials Corp. | 1994-07-07 | 776 | 0 |
| K924725 | AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS | American Biomaterials Corp. | 1993-02-05 | 137 | 0 |
| K915824 | HOLE PUNCH | American Biomaterials Corp. | 1993-01-29 | 396 | 0 |
| K880371 | BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER | American Biomaterials Corp. | 1988-11-18 | 296 | 0 |
| K863796 | CREATIVE CARE SYSTEMS' IV START KIT | American Biomaterials Corp. | 1986-11-28 | 60 | 0 |
| K843461 | BIOGLASS OSSICULAR RECONSTRUCTION PROSTH | American Biomaterials Corp. | 1985-01-09 | 126 | 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