Morgan Scientific, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Morgan Scientific, Inc.” (first 2002, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 172 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 92 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 214 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Morgan Scientific, Inc. took a median 153 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 215 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 5 | 5 |
| JEH | Plethysmograph, Volume | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Morgan Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213872 | ComPAS2 | BZG | 2022-07-15 | 214 |
| K190568 | ComPAS2 (Computerized Pulmonary Analysis System) | BZG | 2019-06-06 | 92 |
| K042595 | SPIRO'AIR | BZG | 2005-05-04 | 223 |
| K022636 | BODY BOX 5500 | JEH | 2003-01-13 | 158 |
| K021200 | COMPAS | BZG | 2002-10-18 | 185 |
| K013752 | COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) | BZG | 2002-01-30 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Morgan Scientific, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Morgan Associates, Inc. (2 510(k)s)
- Morgan Medical , Ltd. (2 510(k)s)
- Morgan Technology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Morgan Scientific, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Morgan Scientific, Inc.” (first 2002, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Morgan Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Morgan Scientific, Inc. is 172 days.
Which FDA product codes appear under Morgan Scientific, Inc.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 5); JEH (Plethysmograph, Volume, 1).
Next steps
- See all 6 Morgan Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Morgan Scientific, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.