Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microwave Medical Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
303 daysmedian FDA review time
649 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974387 | PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, | Microwave Medical Systems, Inc. | 1999-09-01 | 649 | 0 |
| K932083 | XDCS-100 | Microwave Medical Systems, Inc. | 1993-12-16 | 230 | 0 |
| K914867 | QWIK-1(TM) IN-LINE IV FLUID WARMER | Microwave Medical Systems, Inc. | 1992-10-23 | 360 | 0 |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | Microwave Medical Systems, Inc. | 1991-10-10 | 90 | 0 |
| K900295 | PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES | Microwave Medical Systems, Inc. | 1990-11-21 | 303 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda