Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Brentwood Medical Technology Corp. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
165 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103640 | MIDMARK IQECG | Brentwood Medical Technology Corp. | 2011-03-22 | 99 | 0 |
| K100913 | IQVITALS AND IQVITALS SYSTEM | Brentwood Medical Technology Corp. | 2010-05-26 | 55 | 0 |
| K052898 | IQMARK EZ STRESS | Brentwood Medical Technology Corp. | 2006-03-28 | 165 | 0 |
| K031466 | IQMARK DIGITAL HOLTER | Brentwood Medical Technology Corp. | 2003-06-11 | 34 | 0 |
| K013717 | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBR | Brentwood Medical Technology Corp. | 2002-02-06 | 90 | 0 |
| K010505 | TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY | Brentwood Medical Technology Corp. | 2001-03-09 | 16 | 0 |
| K002499 | BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNE | Brentwood Medical Technology Corp. | 2000-11-08 | 86 | 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