Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quantum Medical Systems, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
360 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904019 | QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Medical Systems, Inc. | 1991-03-22 | 204 | 0 |
| K894992 | QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Medical Systems, Inc. | 1990-02-23 | 199 | 0 |
| K890998 | QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. | Quantum Medical Systems, Inc. | 1989-05-02 | 88 | 0 |
| K860581 | QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Medical Systems, Inc. | 1987-02-13 | 360 | 0 |
| K853217 | QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES | Quantum Medical Systems, Inc. | 1985-12-30 | 151 | 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