Litton Medical Electronics: FDA clearances and approvals
Litton Medical Electronics has 38 FDA 510(k) clearances (first 1982, latest 1985), across 11 product codes in 3 review panels. Median 510(k) review time: 146 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) | 17 | 17 |
| DPS | Electrocardiograph | 5 | 5 |
| DXJ | Display, Cathode-Ray Tube, Medical | 5 | 5 |
| DSF | Recorder, Paper Chart | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (35)
- Anesthesiology (2)
- General Hospital (1)
Most recent Litton Medical Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840522 | RECOMED BLOOD-FLOW METER H236-052-02 | DPW | 1985-05-16 | 464 |
| K840899 | SERVOMED ARRHYCOMP CENTRAL MONITOR SYS | DSI | 1984-11-20 | 266 |
| K840439 | RECOMED CARDIAC OUTPUT METER 236067- | DXG | 1984-11-20 | 293 |
| K840523 | SERVOMED PULSE AMPLIFIER MODULE-206- | DRT | 1984-10-29 | 265 |
| K840524 | SERVOMED BASIC BEDSIDE UNIT SMV 110TP | DRT | 1984-10-26 | 262 |
| K840832 | SERVOMED OXCARDIORE SPIROGRAPH 324/111 | DRT | 1984-09-20 | 209 |
| K840209 | SERVOMED MEDIVISION SCOPE SMV-235 | DXJ | 1984-09-20 | 245 |
| K840525 | SERVOMED COMPACT MONITOR SMK 155-1/101 | DRT | 1984-06-01 | 115 |
| K840521 | SERVOMED DIGITAL DISPLAY MODULE | DRT | 1984-06-01 | 115 |
| K834600 | RECOMB ECG PREAMPLIFIER/206 069 03 | DRT | 1984-06-01 | 154 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Litton Medical Electronics.
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 Medical Electronics have?
Litton Medical Electronics has 38 FDA 510(k) clearances (first 1982, latest 1985), across 11 product codes in 3 review panels.
How long does FDA take to clear Litton Medical Electronics's 510(k)s?
The median time from FDA receipt to decision across Litton Medical Electronics's cleared 510(k)s is 146 days.
What devices does Litton Medical Electronics make?
Its most frequent FDA product codes are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 17); DPS (Electrocardiograph, 5); DXJ (Display, Cathode-Ray Tube, Medical, 5).
Has Litton Medical Electronics had device recalls?
openFDA lists no recalls under a recalling firm name matching Litton Medical Electronics. Related entities may recall under other names.
Next steps
- See all 38 Litton Medical Electronics clearances with predicates and recalls
- Run predicate analysis for product code DRT, Litton Medical Electronics'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.