510(k) · Cleared
ClearedMedical Monitor (40HT513D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lg Electronics.Inc · PGY Display, Diagnostic Radiology
Cleared on Jun 12, 2026 as substantially equivalent to K232127 (Lg Electronics.Inc, 2023) after a 59-day review. Its family tree reaches back 9 generations to 2004.
- Decided
- Jun 12, 2026
- Review
- 59 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K033466 (2004). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 5 generations between
- 3 generations backK212295 21HQ513DLg Electronics.Inc · 2021
- 2 generations backK223789 21HQ513DLg Electronics.Inc · 2023
- 1 generation backK232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- This deviceK261213 Medical Monitor (40HT513D)Lg Electronics.Inc · 2026
Show all 9 generations
- Root · 9 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 8 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 7 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 6 generations backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- 5 generations backK153354 3MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016
- 4 generations backK191864 21HK512DLg Electronics.Inc · 2019
- 3 generations backK212295 21HQ513DLg Electronics.Inc · 2021
- 2 generations backK223789 21HQ513DLg Electronics.Inc · 2023
- 1 generation backK232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- This deviceK261213 Medical Monitor (40HT513D)Lg Electronics.Inc · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −8 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −7 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −6 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| −5 | K153354 | 3MP Color LCD Monitor, RadiForce RX350 | Eizo Corporation | 2016 | — |
| −4 | K191864 | 21HK512D | Lg Electronics.Inc | 2019 | — |
| −3 | K212295 | 21HQ513D | Lg Electronics.Inc | 2021 | — |
| −2 | K223789 | 21HQ513D | Lg Electronics.Inc | 2023 | — |
| −1 | K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| 0 (this device) | K261213 | Medical Monitor (40HT513D) | Lg Electronics.Inc | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGY device
- #1 K262783 RadiForce MX247Wscore 12.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713DSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232127 32HL512D PGY Device Descr… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 20 ancestors has a recall.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PGY
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGY
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGY
No recall names PGY since 2007.
Adverse event reports per year · PGY
1in 2017
MAUDE reports naming product code PGY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 14 | 24 | 0 | 0 |
| 2015 | 16 | 31 | 0 | 0 |
| 2016 | 18 | 27 | 0 | 0 |
| 2017 | 11 | 30 | 0 | 1 |
| 2018 | 5 | 28 | 0 | 0 |
| 2019 | 11 | 58 | 0 | 0 |
| 2020 | 12 | 61 | 0 | 0 |
| 2021 | 7 | 77 | 0 | 0 |
| 2022 | 10 | 60 | 0 | 0 |
| 2023 | 17 | 60 | 0 | 0 |
| 2024 | 10 | 53 | 0 | 0 |
| 2025 | 3 | 59 | 0 | 0 |
| 2026 | 4 | 48 | 0 | — |
What is it indicated for?
This Medical Monitor is indicated for use in displaying radiological images and enhancing the image quality for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261213: Medical Monitor (40HT513D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261213
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026