Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biologics Intl., Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
88 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882229 | AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS | Biologics Intl., Inc. | 1988-08-16 | 88 | 0 |
| K823353 | CARCINO-CEK | Biologics Intl., Inc. | 1982-12-14 | 35 | 0 |
| K812060 | BI-ASO SLIDE TEST | Biologics Intl., Inc. | 1981-08-13 | 23 | 0 |
| K811374 | BI-CRP LATEX TEST | Biologics Intl., Inc. | 1981-06-12 | 28 | 0 |
| K811375 | BI-RA SLIDE TEST | Biologics Intl., Inc. | 1981-06-12 | 28 | 0 |
| K800605 | ANA LATEX SLIDE TEST | Biologics Intl., Inc. | 1980-04-02 | 16 | 0 |
| K791609 | BE-SURE | Biologics Intl., Inc. | 1979-10-02 | 53 | 0 |
| K791607 | BETA-CELL | Biologics Intl., Inc. | 1979-09-24 | 41 | 0 |
| K790898 | PREG-TEX | Biologics Intl., Inc. | 1979-07-30 | 82 | 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