Lg Electronics.Inc: FDA clearances and approvals
Lg Electronics.Inc has 33 FDA 510(k) clearances (first 2014, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time: 64 days. Since 2017 its median was 64 days, against 92 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 329 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 103 |
| 2018 | 3 | 50 |
| 2019 | 3 | 27 |
| 2020 | 3 | 148 |
| 2021 | 2 | 144 |
| 2022 | 6 | 60 |
| 2023 | 6 | 46 |
| 2024 | 3 | 87 |
| 2025 | 2 | 69 |
| 2026 | 2 | 61 |
Review time against the same product codes
Since 2017, Lg Electronics.Inc's cleared 510(k)s took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | 12 | 12 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 9 | 9 |
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| OAP | Laser, Comb, Hair | 1 | 1 |
Review panels
- Radiology (24)
- General and Plastic Surgery (8)
- Cardiovascular (1)
Most recent Lg Electronics.Inc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261614 | LED LCD Monitor (OEV-271H) | GCJ | 2026-07-17 | 63 |
| K261213 | Medical Monitor (40HT513D) | PGY | 2026-06-12 | 59 |
| K251209 | Medical Monitor (32HS710S) | GCJ | 2025-06-12 | 55 |
| K243439 | Medical Monitor (27HS714S) | GCJ | 2025-01-28 | 83 |
| K241402 | Medical Monitor (32HR734S) | GCJ | 2024-08-12 | 87 |
| K233599 | X-Clever (ASHK100G) | LLZ | 2024-03-18 | 130 |
| K240130 | Medical Monitor (21HQ613D) | PGY | 2024-02-15 | 29 |
| K232985 | 24HR513C | PGY | 2023-12-11 | 80 |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | PGY | 2023-08-15 | 29 |
| K230845 | 32HL512D, 31HN713D, 32HQ713D | PGY | 2023-04-27 | 30 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lg Electronics.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 Lg Electronics.Inc have?
Lg Electronics.Inc has 33 FDA 510(k) clearances (first 2014, latest 2026), across 7 product codes in 3 review panels.
How long does FDA take to clear Lg Electronics.Inc's 510(k)s?
The median time from FDA receipt to decision across Lg Electronics.Inc's cleared 510(k)s is 64 days. Since 2017: 64 days, versus 92 days for all cleared 510(k)s in the same product codes.
What devices does Lg Electronics.Inc make?
Its most frequent FDA product codes are PGY (Display, Diagnostic Radiology, 12); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 9); GCJ (Laparoscope, General & Plastic Surgery, 5).
Has Lg Electronics.Inc had device recalls?
openFDA lists no recalls under a recalling firm name matching Lg Electronics.Inc. Related entities may recall under other names.
Next steps
- See all 33 Lg Electronics.Inc clearances with predicates and recalls
- Run predicate analysis for product code PGY, Lg Electronics.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.