Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Life Sensing Instrument Company, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
557 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960884 | TELE TRENS TM 10 | Life Sensing Instrument Company, Inc. | 1997-09-12 | 557 | 0 |
| K931136 | APOLLO CAMERA | Life Sensing Instrument Company, Inc. | 1994-01-11 | 312 | 0 |
| K896967 | HTS 820 CARDIAC MONITOR | Life Sensing Instrument Company, Inc. | 1990-03-19 | 91 | 0 |
| K884524 | HTS 220 CARDIAC MONITOR | Life Sensing Instrument Company, Inc. | 1989-04-10 | 165 | 0 |
| K861067 | PARAGON 420, CARDIAC MONITOR | Life Sensing Instrument Company, Inc. | 1986-06-05 | 77 | 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