Mag, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Mag, Inc.” (first 1993, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 15 | 15 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (16)
- General Hospital (1)
Most recent Mag, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942136 | M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS | CAI | 1994-06-22 | 50 |
| K942135 | M.A.G. INC. COAXIAL CIRCUITS | CAI | 1994-06-22 | 50 |
| K942134 | M.A.G. INC. BREALTHING BAGS | CAI | 1994-06-22 | 50 |
| K942133 | M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS | CAI | 1994-06-22 | 50 |
| K942132 | M.A.G. INC. HYPERINFLATION SYSTEM | CAI | 1994-06-22 | 50 |
| K942131 | M.A.G. INC. GUEDEL AIRWAYS | CAI | 1994-06-22 | 50 |
| K942130 | M.A.G. INC. MAPLESON D CIRCUITS | CAI | 1994-06-22 | 50 |
| K942129 | M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | CAI | 1994-06-22 | 50 |
| K942128 | M.A.G. INC. ADULT GAS SAMPLING CIRCUITS | CAI | 1994-06-22 | 50 |
| K942127 | M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS | CAI | 1994-06-22 | 50 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mag, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mag, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Mag, Inc.” (first 1993, latest 1994), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mag, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mag, Inc. is 50 days.
Which FDA product codes appear under Mag, Inc.?
The most frequent FDA product codes under this applicant name are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 15); BZA (Connector, Airway (Extension), 1); CAH (Filter, Bacterial, Breathing-Circuit, 1).
Next steps
- See all 17 Mag, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAI, Mag, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.