Matrix Medica, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Matrix Medica, Inc.” (first 1985, latest 1996), across 13 product codes in 7 review panels. Median 510(k) review time under this name: 97 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| DRL | Tester, Defibrillator | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| GDB | Endoscope, Fiber Optic | 1 | 1 |
| ILI | Sling, Arm | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Plus 3 more product codes.
Review panels
- Anesthesiology (3)
- Cardiovascular (3)
- Dental (2)
- General Hospital (2)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Matrix Medica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961536 | FLEXSCOPE | GDB | 1996-09-18 | 149 |
| K923693 | KLORMAN | LRJ | 1996-01-23 | 1279 |
| K921982 | MATRX HOPE(R) 5 RESUSCITATOR | BTM | 1994-10-28 | 913 |
| K915353 | MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP | EIA | 1991-12-27 | 31 |
| K912661 | MATRX, PYRAMID TRIANGLE BANDAGE | ILI | 1991-08-21 | 64 |
| K900551 | MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. | DRS | 1990-05-09 | 92 |
| K895533 | LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER | LDD | 1990-01-26 | 135 |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | DRL | 1990-01-26 | 136 |
| K893219 | MATRX DENTAL UNIT | EIA | 1989-08-07 | 102 |
| K883833 | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) | BZR | 1989-02-17 | 161 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Matrix Medica, 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.
- Matrix Instruments (4 510(k)s)
- Matrix Technologies Corp. (3 510(k)s)
- Matrix Electromedical, Inc. (2 510(k)s)
- Matrix Surgical Holdings, LLC/Matrix Surgical USA (2 510(k)s)
- Matrix Biokinetics, Inc. (1 510(k)s)
- Matrix Intl. (1 510(k)s)
- Matrix Surgical USA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Matrix Medica, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Matrix Medica, Inc.” (first 1985, latest 1996), across 13 product codes in 7 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 Matrix Medica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Matrix Medica, Inc. is 97 days.
Which FDA product codes appear under Matrix Medica, Inc.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 2); BSZ (Gas-Machine, Anesthesia, 1); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Next steps
- See all 14 Matrix Medica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Matrix Medica, 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.