Mega Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mega Medical, Inc.” (first 1991, latest 1992), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent Mega Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915863 | MEGA AMNIOCENTESIS KIT | HIO | 1992-03-30 | 90 |
| K913397 | MEGA ANGIOGRAM KIT | DQO | 1991-10-31 | 93 |
| K913317 | MEGA ARTHROGRAM KIT | FMI | 1991-10-31 | 98 |
| K912445 | MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT | CAZ | 1991-10-18 | 137 |
| K913382 | MEGA PARACENTESIS KIT | KKX | 1991-10-08 | 71 |
| K912322 | MEGA SPINAL ANESTHESIA KIT | CAZ | 1991-09-26 | 125 |
| K912564 | MEGA PERICARDIOCENTESIS KIT | DQY | 1991-09-05 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Mega Medical, 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.
- Mega Electronics , Ltd. (4 510(k)s)
- Mega Motion, Inc. (4 510(k)s)
- Mega Meditex , Ltd. (1 510(k)s)
- Mega Services (1 510(k)s)
- Mega-Tech Intl., Inc. (1 510(k)s)
- Mega Wijaya Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mega Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Mega Medical, Inc.” (first 1991, latest 1992), across 6 product codes in 4 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 Mega Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mega Medical, Inc. is 93 days.
Which FDA product codes appear under Mega Medical, Inc.?
The most frequent FDA product codes under this applicant name are CAZ (Anesthesia Conduction Kit, 2); DQO (Catheter, Intravascular, Diagnostic, 1); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 7 Mega Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAZ, Mega Medical, 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.