Microwave Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Microwave Medical Systems, Inc.” (first 1990, latest 1999), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 303 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 2 | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 | 1 |
Review panels
Most recent Microwave Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974387 | PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE | KDJ | 1999-09-01 | 649 |
| K932083 | XDCS-100 | DXT | 1993-12-16 | 230 |
| K914867 | QWIK-1(TM) IN-LINE IV FLUID WARMER | LGZ | 1992-10-23 | 360 |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | DRQ | 1991-10-10 | 90 |
| K900295 | PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES | KDJ | 1990-11-21 | 303 |
Recalls
openFDA lists no recalls under a recalling firm named Microwave Medical Systems, 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.
- Microwave Development, Inc. (1 510(k)s)
- Microwave Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microwave Medical Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Microwave Medical Systems, Inc.” (first 1990, latest 1999), across 4 product codes in 3 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 Microwave Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microwave Medical Systems, Inc. is 303 days.
Which FDA product codes appear under Microwave Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 2); DRQ (Amplifier And Signal Conditioner, Transducer Signal, 1); DXT (Injector And Syringe, Angiographic, 1).
Next steps
- See all 5 Microwave Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDJ, Microwave Medical Systems, 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.