Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Non-Invasive Monitoring Systems, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
263 daysmedian FDA review time
610 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012020 | RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A | Non-Invasive Monitoring Systems, Inc. | 2001-08-21 | 54 | 0 |
| K001369 | RESPIEVENTS, VERSION 4.2 | Non-Invasive Monitoring Systems, Inc. | 2000-07-26 | 86 | 0 |
| K942771 | RESPIEVENTS | Non-Invasive Monitoring Systems, Inc. | 1996-02-13 | 610 | 0 |
| K942852 | RESPITRACE PT | Non-Invasive Monitoring Systems, Inc. | 1996-02-13 | 610 | 0 |
| K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL | Non-Invasive Monitoring Systems, Inc. | 1991-03-29 | 263 | 0 |
| K884959 | RESPITRAK | Non-Invasive Monitoring Systems, Inc. | 1989-06-08 | 191 | 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