Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qrs Diagnostic, LLC — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
433 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083749 | CARDIOVIEW32 REVIEW MODULE | Qrs Diagnostic, LLC | 2009-03-10 | 83 | 0 |
| K073630 | MODIFICATION TO: BPCARD, MODEL Z-7000-0700 | Qrs Diagnostic, LLC | 2008-01-11 | 16 | 0 |
| K031964 | BPCARD | Qrs Diagnostic, LLC | 2003-09-05 | 72 | 0 |
| K030535 | EKGCARD SYSTEM | Qrs Diagnostic, LLC | 2003-06-11 | 111 | 0 |
| K001278 | SENSAIRE DIAGNOSTIC SPIROMETER | Qrs Diagnostic, LLC | 2000-11-29 | 222 | 0 |
| K001995 | SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER | Qrs Diagnostic, LLC | 2000-09-08 | 70 | 0 |
| K973138 | SPIROCARD | Qrs Diagnostic, LLC | 1998-10-28 | 433 | 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