Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biovation, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
133 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925528 | BIOVATION K-MANAGER | Biovation, Inc. | 1993-02-05 | 95 | 0 |
| K923844 | LYRIS 100/120 LABORATORY INFORMATION SYSTEM | Biovation, Inc. | 1992-12-11 | 133 | 0 |
| K915071 | DIFFERENTIAL COUNTING BOARD | Biovation, Inc. | 1992-01-17 | 70 | 0 |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | Biovation, Inc. | 1985-08-02 | 15 | 0 |
| K842401 | CHEMISTRY CONSOLE | Biovation, Inc. | 1984-09-04 | 77 | 0 |
| K831830 | LYRIS MODULAR INFO SYSTEM | Biovation, Inc. | 1984-06-25 | 384 | 0 |
| K821534 | HEMATOLOGY DATA MANAGEMENT SYS | Biovation, Inc. | 1982-06-10 | 17 | 0 |
| K812604 | BIOVATION URINALYSIS REPORTER | Biovation, Inc. | 1981-10-02 | 17 | 0 |
| K792045 | BIOVATION NEPHELOMETER | Biovation, Inc. | 1979-10-30 | 18 | 0 |
| K790862 | BIOVATION DIGITAL URINOMETER | Biovation, Inc. | 1979-06-28 | 52 | 0 |
| K781644 | ANTIBIOTIC NEPHELOMETER | Biovation, Inc. | 1978-10-03 | 8 | 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