Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JSP — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
69 daysmedian FDA review time
188 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945488 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 | 184 | 0 |
| K945489 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 | 184 | 0 |
| K945487 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 | 184 | 0 |
| K944528 | BBLCRYSTAL ANAEROBE ID SYSTEM | Becton Dickinson Microbiology Systems | 1995-03-07 | 173 | 0 |
| K910666 | VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION | Vitek Systems, Inc. | 1991-04-03 | 51 | 0 |
| K900996 | VITEK ANAEROBE IDENTIFICATION CARD | Vitek Systems, Inc. | 1990-05-11 | 70 | 0 |
| K881380 | B. FRAGTEX | American Biomedical Products, Inc. | 1988-10-06 | 188 | 0 |
| K882960 | IDS RAPID ANA SYSTEM | Innovative Diagnostic Systems, Inc. | 1988-08-12 | 29 | 0 |
| K855235 | DIAGNOSTIC REAGENT PET-RPLA | Oxoid U.S.A., Inc. | 1986-11-04 | 308 | 0 |
| K862332 | ANAEROBE RAPID CHROMOGENIC ID PANEL | American Micro Scan | 1986-08-27 | 69 | 0 |
| K850052 | ANAEROBE KIT | Austin Biological Laboratories | 1985-03-05 | 56 | 0 |
| K843686 | AMS ANA CARD | Vitek Systems, Inc. | 1984-12-12 | 85 | 0 |
| K831032 | API ANAIDENT | Analytical Products, Inc. | 1983-05-05 | 36 | 0 |
| K830964 | ANAEROBE MIC/ID TEMPLATE, & TAXONOMY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-05-04 | 37 | 0 |
| K820483 | IDA RAPID O2A SYSTEM | Innovative Diagnostic Systems, Inc. | 1982-03-15 | 21 | 0 |
| K802626 | ANAIROBE-TEK | Flow Laboratories, Inc. | 1980-11-12 | 20 | 0 |
| K801547 | TEST PANEL FOR PRESUMP. ID/BACT. ORG | Micro-Media Systems, Inc. | 1980-09-09 | 64 | 0 |
| K771616 | API 20A | Analytical Products, Inc. | 1977-09-02 | 9 | 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