Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life Science Instrumentation, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
250 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850812 | EMERGIPACE - EXTERNAL PACEMAKER | Life Science Instrumentation, Inc. | 1985-11-05 | 250 | 0 |
| K842037 | LS 5 | Life Science Instrumentation, Inc. | 1985-03-01 | 294 | 0 |
| K843396 | LS-260G MONITOR/RECORDER & DEFIBILLATOR | Life Science Instrumentation, Inc. | 1984-10-19 | 51 | 0 |
| K840246 | MINI-DEFIBRILLATOR 280/4 | Life Science Instrumentation, Inc. | 1984-04-17 | 96 | 0 |
| K822617 | VPD540 DEFIBRILLATOR | Life Science Instrumentation, Inc. | 1983-04-28 | 241 | 0 |
| K831056 | DEFIBRILLATOR VPD 545 | Life Science Instrumentation, Inc. | 1983-04-28 | 27 | 0 |
| K822616 | LS6 ARRYTHMIA DISCRIMINATOR | Life Science Instrumentation, Inc. | 1982-10-18 | 49 | 0 |
| K822390 | LIFE TRACE 24 | Life Science Instrumentation, Inc. | 1982-09-21 | 43 | 0 |
| K822615 | LIFE WATCH LSI | Life Science Instrumentation, Inc. | 1982-09-21 | 22 | 0 |
| K822389 | LIFE TRACE 40/42 | Life Science Instrumentation, Inc. | 1982-09-21 | 43 | 0 |
| K822294 | VPD-261 DEFIBRILLATOR MONITOR | Life Science Instrumentation, Inc. | 1982-08-31 | 29 | 0 |
| K822388 | LIFE TRACE 14 | Life Science Instrumentation, Inc. | 1982-08-24 | 15 | 0 |
| K821223 | CR-9 | Life Science Instrumentation, Inc. | 1982-06-17 | 51 | 0 |
| K820122 | PIONEER II BACK PLATE ELECTRODE | Life Science Instrumentation, Inc. | 1982-03-01 | 42 | 0 |
| K812144 | CENTERAL MONITOR 360 | Life Science Instrumentation, Inc. | 1981-09-25 | 59 | 0 |
| K812145 | CARDIORATER CR-3 | Life Science Instrumentation, Inc. | 1981-09-25 | 59 | 0 |
| K812147 | CARDIORATER CR-7 | Life Science Instrumentation, Inc. | 1981-09-25 | 59 | 0 |
| K812519 | 2000 SERIES PORTABLE RESUSCITATION SYST. | Life Science Instrumentation, Inc. | 1981-09-25 | 23 | 0 |
| K812146 | CARDIORATER CR-5 | Life Science Instrumentation, Inc. | 1981-09-25 | 59 | 0 |
| K812520 | 280/4 MINI-DEFIBRILLATOR | Life Science Instrumentation, Inc. | 1981-09-25 | 23 | 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