Litton Datamedix: FDA clearances and approvals
Litton Datamedix has 5 FDA 510(k) clearances (first 1984, latest 1986), across 4 product codes in 3 review panels. Median 510(k) review time: 84 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 | 1 |
Review panels
- Cardiovascular (3)
- Anesthesiology (1)
- Radiology (1)
Most recent Litton Datamedix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853599 | LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI | DXN | 1986-03-21 | 206 |
| K850290 | ULTRASOUND GEL | IYO | 1985-04-18 | 84 |
| K842497 | SERVOMED OXYMONITO SMK 363 | KLK | 1984-10-04 | 100 |
| K842312 | SERVOCARD SCP-840 | LDD | 1984-08-27 | 76 |
| K842235 | SERVOCARD DEFIBRILLATOR SCP-851 | LDD | 1984-08-27 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Litton Datamedix.
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 Litton Datamedix have?
Litton Datamedix has 5 FDA 510(k) clearances (first 1984, latest 1986), across 4 product codes in 3 review panels.
How long does FDA take to clear Litton Datamedix's 510(k)s?
The median time from FDA receipt to decision across Litton Datamedix's cleared 510(k)s is 84 days.
What devices does Litton Datamedix make?
Its most frequent FDA product codes are LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Has Litton Datamedix had device recalls?
openFDA lists no recalls under a recalling firm name matching Litton Datamedix. Related entities may recall under other names.
Next steps
- See all 5 Litton Datamedix clearances with predicates and recalls
- Run predicate analysis for product code LDD, Litton Datamedix'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.