Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S & S Inficon, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922977 | EXPOSET | S & S Inficon, Inc. | 1992-11-27 | 163 | 0 |
| K920455 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.) | S & S Inficon, Inc. | 1992-03-31 | 75 | 0 |
| K911454 | FC2000 | S & S Inficon, Inc. | 1991-07-15 | 103 | 0 |
| K902339 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER | S & S Inficon, Inc. | 1990-08-23 | 91 | 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