Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shared Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
281 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973457 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 | Shared Systems, Inc. | 1998-01-02 | 112 | 0 |
| K955042 | CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM | Shared Systems, Inc. | 1995-12-13 | 40 | 0 |
| K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYST | Shared Systems, Inc. | 1995-10-17 | 281 | 0 |
| K953261 | CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM | Shared Systems, Inc. | 1995-08-15 | 34 | 0 |
| K920212 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM | Shared Systems, Inc. | 1992-08-20 | 217 | 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