Mast Immunosystems: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Mast Immunosystems” (first 1983, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 10 | 10 |
| DGC | Ige, Antigen, Antiserum, Control | 3 | 3 |
Review panels
- Immunology (13)
Most recent Mast Immunosystems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934524 | MAST CLA ALLERGY SYSTEM | DHB | 1994-03-07 | 168 |
| K926420 | MAST CLA ALLERGY SYSTEM | DHB | 1994-03-07 | 439 |
| K914850 | CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE | DHB | 1991-12-09 | 42 |
| K910292 | MAST CLA ALLERGY SYSTEM | DHB | 1991-04-05 | 72 |
| K870966 | TOTAL IGE MASTICK | DHB | 1987-04-14 | 35 |
| K844629 | MAST LUMINESCENT ALLERGY SYSTEM | DHB | 1985-04-12 | 136 |
| K843694 | MAST ALLERGY SYSTEM | DHB | 1985-04-12 | 205 |
| K841642 | MAST LUMINESCENT ALLERGY SYS | DGC | 1984-06-07 | 48 |
| K834526 | MAST INHALANT PROFILE | DHB | 1984-04-04 | 105 |
| K833969 | MAST TOTAL IGE | DGC | 1984-01-04 | 49 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mast Immunosystems.
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.
- Mast Biosurgery USA, Inc. (4 510(k)s)
- Mast Biosurgery (2 510(k)s)
- Mast Group , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mast Immunosystems?
FDA lists 13 510(k) clearances under the applicant name “Mast Immunosystems” (first 1983, latest 1994), 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 Mast Immunosystems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mast Immunosystems is 72 days.
Which FDA product codes appear under Mast Immunosystems?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 10); DGC (Ige, Antigen, Antiserum, Control, 3).
Next steps
- See all 13 Mast Immunosystems clearances with predicates and recalls
- Run predicate analysis for product code DHB, Mast Immunosystems'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.