Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Invivo Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 | Invivo Corp. | 2009-12-15 | 267 | 2 |
| K052704 | MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE | Invivo Corp. | 2005-11-03 | 36 | 0 |
| K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A | Invivo Corp. | 2005-10-12 | 30 | 0 |
| K051512 | CAC-127-8 CARDOAC ARRAY COIL | Invivo Corp. | 2005-06-28 | 21 | 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