Life Sensing Instrument Company, Inc.: FDA clearances and approvals
Life Sensing Instrument Company, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time: 165 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Review panels
Most recent Life Sensing Instrument Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960884 | TELE TRENS TM 10 | DSI | 1997-09-12 | 557 |
| K931136 | APOLLO CAMERA | HET | 1994-01-11 | 312 |
| K896967 | HTS 820 CARDIAC MONITOR | DSI | 1990-03-19 | 91 |
| K884524 | HTS 220 CARDIAC MONITOR | DSI | 1989-04-10 | 165 |
| K861067 | PARAGON 420, CARDIAC MONITOR | DPS | 1986-06-05 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Life Sensing Instrument Company, 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 Sensing Instrument Company, Inc. have?
Life Sensing Instrument Company, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1997), across 3 product codes in 2 review panels.
How long does FDA take to clear Life Sensing Instrument Company, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Life Sensing Instrument Company, Inc.'s cleared 510(k)s is 165 days.
What devices does Life Sensing Instrument Company, Inc. make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 3); DPS (Electrocardiograph, 1); HET (Laparoscope, Gynecologic (And Accessories), 1).
Has Life Sensing Instrument Company, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Life Sensing Instrument Company, Inc. Related entities may recall under other names.
Next steps
- See all 5 Life Sensing Instrument Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Life Sensing Instrument Company, 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.