Life Science Instrumentation, Inc.: FDA clearances and approvals
Life Science Instrumentation, Inc. has 20 FDA 510(k) clearances (first 1981, latest 1985), across 5 product codes in 1 review panel. Median 510(k) review time: 50 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 10 | 10 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 7 | 7 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 1 | 1 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
Review panels
- Cardiovascular (20)
Most recent Life Science Instrumentation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850812 | EMERGIPACE - EXTERNAL PACEMAKER | DRO | 1985-11-05 | 250 |
| K842037 | LS 5 | DRT | 1985-03-01 | 294 |
| K843396 | LS-260G MONITOR/RECORDER & DEFIBILLATOR | LDD | 1984-10-19 | 51 |
| K840246 | MINI-DEFIBRILLATOR 280/4 | LDD | 1984-04-17 | 96 |
| K831056 | DEFIBRILLATOR VPD 545 | LDD | 1983-04-28 | 27 |
| K822617 | VPD540 DEFIBRILLATOR | LDD | 1983-04-28 | 241 |
| K822616 | LS6 ARRYTHMIA DISCRIMINATOR | DSI | 1982-10-18 | 49 |
| K822615 | LIFE WATCH LSI | DRT | 1982-09-21 | 22 |
| K822390 | LIFE TRACE 24 | DRT | 1982-09-21 | 43 |
| K822389 | LIFE TRACE 40/42 | DRT | 1982-09-21 | 43 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life Science Instrumentation, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Life Science Instrumentation, Inc. have?
Life Science Instrumentation, Inc. has 20 FDA 510(k) clearances (first 1981, latest 1985), across 5 product codes in 1 review panel.
How long does FDA take to clear Life Science Instrumentation, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Life Science Instrumentation, Inc.'s cleared 510(k)s is 50 days.
What devices does Life Science Instrumentation, Inc. make?
Its most frequent FDA product codes are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 10); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 7); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 1).
Has Life Science Instrumentation, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Life Science Instrumentation, Inc. Related entities may recall under other names.
Next steps
- See all 20 Life Science Instrumentation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Life Science Instrumentation, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.