Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integra Neurosciences — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
87 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | Integra Neurosciences | 2008-10-10 | 63 | 0 |
| K050720 | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MO | Integra Neurosciences | 2005-05-11 | 51 | 1 |
| K031086 | CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 | Integra Neurosciences | 2003-05-14 | 37 | 0 |
| K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 153 | Integra Neurosciences | 2002-09-13 | 87 | 2 |
| K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | Integra Neurosciences | 2002-08-23 | 21 | 2 |
| K022553 | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX | Integra Neurosciences | 2002-08-20 | 18 | 0 |
| K020558 | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | Integra Neurosciences | 2002-03-21 | 29 | 0 |
| K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1. | Integra Neurosciences | 2000-11-24 | 80 | 3 |
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