Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OLY · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
247 daysmedian FDA review time
324 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191785 | Orion LifeSpan MEG | Compumedics Limited | 2020-02-14 | 226 | 0 |
| K152184 | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | 2016-04-08 | 247 | 0 |
| K133419 | BABYMEG BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | 2014-07-21 | 256 | 0 |
| K962317 | MAGNES 2500 WH BIOMAGNETOMETER | Biomagnetic Technologies, Inc. | 1997-05-07 | 324 | 0 |
| K962764 | NEUROMAG-122 | Philips Medical Systems (Cleveland), Inc. | 1996-10-31 | 107 | 0 |
| K854466 | BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER | Biomagnetic Technologies, Inc. | 1986-02-04 | 90 | 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