Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Morgan Scientific, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
185 daysmedian FDA review time
223 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213872 | ComPAS2 | Morgan Scientific, Inc. | 2022-07-15 | 214 | 0 |
| K190568 | ComPAS2 (Computerized Pulmonary Analysis System) | Morgan Scientific, Inc. | 2019-06-06 | 92 | 0 |
| K042595 | SPIRO'AIR | Morgan Scientific, Inc. | 2005-05-04 | 223 | 0 |
| K022636 | BODY BOX 5500 | Morgan Scientific, Inc. | 2003-01-13 | 158 | 0 |
| K021200 | COMPAS | Morgan Scientific, Inc. | 2002-10-18 | 185 | 0 |
| K013752 | COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) | Morgan Scientific, Inc. | 2002-01-30 | 78 | 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