Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Contour Medical Technology, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
290 daysmedian FDA review time
290 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970391 | QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES | Contour Medical Technology, Inc. | 1997-03-06 | 31 | 0 |
| K970125 | NOAH MONITORING ELECTRODE SYSTEM | Contour Medical Technology, Inc. | 1997-03-04 | 49 | 0 |
| K960329 | DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD | Contour Medical Technology, Inc. | 1996-07-02 | 160 | 1 |
| K952801 | TEMPERATURE PROBE-TP250 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952800 | TEMPERATURE PROBE-TP150 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952805 | TEMPERATURE PROBE-TP550 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952803 | TEMPERATURE PROBE-TP350 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952807 | TEMPERATURE PROBE-TP650 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 0 |
| K952804 | TEMPERATURE PROBE-TP450 | Contour Medical Technology, Inc. | 1996-04-04 | 290 | 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