Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
North East Monitoring, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
805 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142424 | DR300 HOLTER MONITOR | North East Monitoring, Inc. | 2014-11-25 | 88 | 0 |
| K081861 | HOLTER LX ANALYSIS | North East Monitoring, Inc. | 2008-12-04 | 156 | 0 |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | North East Monitoring, Inc. | 2007-05-25 | 142 | 0 |
| K061293 | TELAHEART DIGITAL RECORDER | North East Monitoring, Inc. | 2006-08-25 | 108 | 0 |
| K041901 | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | North East Monitoring, Inc. | 2004-08-31 | 48 | 0 |
| K004007 | DR180+OXY | North East Monitoring, Inc. | 2001-01-25 | 30 | 0 |
| K001288 | DR180-II | North East Monitoring, Inc. | 2000-07-20 | 87 | 0 |
| K983576 | DR180-R/OXY | North East Monitoring, Inc. | 1999-03-23 | 161 | 0 |
| K960925 | NORTHEAST MONITORING DR180 | North East Monitoring, Inc. | 1996-07-31 | 147 | 0 |
| K930564 | HOLTER FOR WINDOWS | North East Monitoring, Inc. | 1995-04-19 | 805 | 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