510(k) · Cleared
ClearedHisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qingdao Hisense Medical Equipment Co., Ltd. · PGY Display, Diagnostic Radiology
Cleared on Sep 16, 2015 as substantially equivalent to K131246 (Barco N.V., 2013) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Sep 16, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K131246 (2013). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK131246 Coronis 3MPBarco N.V. · 2013
- This deviceK152030 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)Qingdao Hisense Medical Equipment Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K131246 | Coronis 3MP | Barco N.V. | 2013 | — |
| 0 (this device) | K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | Qingdao Hisense Medical Equipment Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K131246 | Coronis 3MPSummary page 4…R 807.92(a) (3)] The identified predicates within this submission are as follows: BARCO N.V., Coronis 3MP (MDCG-3221) has been cleared by FDA through 510(k) No.K131246 (Decision Date –May 24, 2013), BARCO N.V., Nio 2MP (MDNC-2221) has been cleared by FDA through 510(k) No K133663 (Decision… | 2013 |
| * | K133663 | Nio Color 2MPSummary page 4…3221) has been cleared by FDA through 510(k) No.K131246 (Decision Date –May 24, 2013), BARCO N.V., Nio 2MP (MDNC-2221) has been cleared by FDA through 510(k) No K133663 (Decision Date –03/25/2014) 510(k) Summary 7-1 === Page 5… | 2014 |
| * | — | Nio 3MP (MDNC-3221) Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K131246.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152030: Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152030
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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