Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Para Scientific Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
41 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021420 | PARACON II/FECAL CONCENTRATOR II | Para Scientific Co. | 2002-06-04 | 32 | 0 |
| K964144 | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AN | Para Scientific Co. | 1996-11-27 | 41 | 0 |
| K881649 | MODIFIED PARACON(TM) CONCENTRATION KIT | Para Scientific Co. | 1988-04-21 | 6 | 0 |
| K872751 | FLUORTRAN - C(TM) | Para Scientific Co. | 1987-07-23 | 10 | 0 |
| K853715 | PARA CON TM | Para Scientific Co. | 1985-10-02 | 28 | 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