Qrs Diagnostic, LLC: FDA clearances and approvals
Qrs Diagnostic, LLC has 7 FDA 510(k) clearances (first 1998, latest 2009), across 5 product codes in 2 review panels. Median 510(k) review time: 83 days. openFDA lists 1 product recall by a recalling firm named Qrs Diagnostic, LLC.
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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| LOS | 1 | 1 |
Review panels
- Anesthesiology (3)
- Cardiovascular (3)
Most recent Qrs Diagnostic, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083749 | CARDIOVIEW32 REVIEW MODULE | LOS | 2009-03-10 | 83 |
| K073630 | MODIFICATION TO: BPCARD, MODEL Z-7000-0700 | DXN | 2008-01-11 | 16 |
| K031964 | BPCARD | DXN | 2003-09-05 | 72 |
| K030535 | EKGCARD SYSTEM | DPS | 2003-06-11 | 111 |
| K001278 | SENSAIRE DIAGNOSTIC SPIROMETER | BZG | 2000-11-29 | 222 |
| K001995 | SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER | DQA | 2000-09-08 | 70 |
| K973138 | SPIROCARD | BZG | 1998-10-28 | 433 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-02-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Qrs Diagnostic, LLC have?
Qrs Diagnostic, LLC has 7 FDA 510(k) clearances (first 1998, latest 2009), across 5 product codes in 2 review panels.
How long does FDA take to clear Qrs Diagnostic, LLC's 510(k)s?
The median time from FDA receipt to decision across Qrs Diagnostic, LLC's cleared 510(k)s is 83 days.
What devices does Qrs Diagnostic, LLC make?
Its most frequent FDA product codes are BZG (Spirometer, Diagnostic, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); DPS (Electrocardiograph, 1).
Has Qrs Diagnostic, LLC had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Qrs Diagnostic, LLC; the most recent began 2012-02-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Qrs Diagnostic, LLC clearances with predicates and recalls
- Run predicate analysis for product code BZG, Qrs Diagnostic, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.