510(k) · Cleared
Cleared21HK512D
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 Dec 5, 2019 as substantially equivalent to K153354 (Eizo Corporation, 2016) after a 146-day review. Its family tree reaches back 5 generations to 2004. 5 later devices descend from it.
- Decided
- Dec 5, 2019
- Review
- 146 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K033466 (2004). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 4 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 3 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 2 generations backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- 1 generation backK153354 3MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016
- This deviceK191864 21HK512DLg Electronics.Inc · 2019
- Descendant · cites it directly · 4 of its ownK212295 21HQ513DLg Electronics.Inc · 2021
- Descendant · 2 generations on · 3 of its ownK223789 21HQ513DLg Electronics.Inc · 2023
- Descendant · 3 generations on · 1 of its ownK232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · 4 generations on · 0 of its ownK261213 Medical Monitor (40HT513D)Lg Electronics.Inc · 2026
- Descendant · 3 generations on · 0 of its ownK232985 24HR513CLg Electronics.Inc · 2023
Most influential descendants
Showing 5 of 5 · See all- K21229521HQ513DLg Electronics.Inc · 2021 · cites it directly4descendants
- K22378921HQ513DLg Electronics.Inc · 2023 · 2 generations on3descendants
- K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · 3 generations on1descendant
- K261213Medical Monitor (40HT513D)Lg Electronics.Inc · 2026 · 4 generations on0descendants
- K23298524HR513CLg Electronics.Inc · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −4 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −3 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −2 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| −1 | K153354 | 3MP Color LCD Monitor, RadiForce RX350 | Eizo Corporation | 2016 | — |
| 0 (this device) | K191864 | 21HK512D | Lg Electronics.Inc | 2019 | — |
| +1 | K212295 | 21HQ513D | Lg Electronics.Inc | 2021 | — |
| +2 | K223789 | 21HQ513D | Lg Electronics.Inc | 2023 | — |
| +3 | K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +4 | K261213 | Medical Monitor (40HT513D) | Lg Electronics.Inc | 2026 | — |
| +3 | K232985 | 24HR513C | Lg Electronics.Inc | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 1 | 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 K261213 Medical Monitor (40HT513D)score 13.9 · 9 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 |
|---|---|---|---|
| * | K153354 | 3MP Color LCD Monitor, RadiForce RX350Summary page 5…f Predicate Device(s) The identified predicate device within this submission are shown as follow: Predicate Device 510(k) Number: K153354 Applicant: EIZO Corporation Classification Name: Picture archiving and… | 2016 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212295 | 21HQ513D | 2021 | 4 |
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 15 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K212295 (Lg Electronics.Inc, 2021) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K153354.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. The display is not intended for mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191864: 21HK512D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191864
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026