510(k) · Cleared
Cleared31HN713D
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 Oct 8, 2020 as substantially equivalent to K141428 (Barco N.V., 2014) after a 101-day review. Its family tree reaches back 1 generation to 2014. 6 later devices descend from it.
- Decided
- Oct 8, 2020
- Review
- 101 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K141428 (2014). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK141428 MDMC-12133Barco N.V. · 2014
- This deviceK201777 31HN713DLg Electronics.Inc · 2020
- Descendant · cites it directly · 3 of its ownK223423 32HQ713DLg Electronics.Inc · 2023
- Descendant · cites it directly · 2 of its ownK230845 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · 2 generations on · 1 of its ownK232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023
- Descendant · cites it directly · 1 of its ownK221061 21HQ613DLg Electronics.Inc · 2022
- Descendant · 3 generations on · 0 of its ownK261213 Medical Monitor (40HT513D)Lg Electronics.Inc · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K22342332HQ713DLg Electronics.Inc · 2023 · cites it directly3descendants
- K23084532HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · cites it directly2descendants
- K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc · 2023 · 2 generations on1descendant
- K22106121HQ613DLg Electronics.Inc · 2022 · cites it directly1descendant
- K261213Medical Monitor (40HT513D)Lg Electronics.Inc · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K141428 | MDMC-12133 | Barco N.V. | 2014 | — |
| 0 (this device) | K201777 | 31HN713D | Lg Electronics.Inc | 2020 | — |
| +1 | K223423 | 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +1 | K230845 | 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +2 | K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023 | — |
| +1 | K221061 | 21HQ613D | Lg Electronics.Inc | 2022 | — |
| +3 | K261213 | Medical Monitor (40HT513D) | Lg Electronics.Inc | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K141428 | MDMC-12133Summary page 5…[21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Predicate Device ⚫ 510(k) Number: K141428 ⚫ Applicant: BARCO N.V. ⚫ Classification Name: Picture archiving and comm… | 2014 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K223423 (Lg Electronics.Inc, 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201777: 31HN713D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201777
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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