Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

PGY — Predicate Candidate Screening

135 FDA 510(k) clearances under this product code; the 50 most recent screened below.

50 daysmedian FDA review time
121 days90th percentile
135clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261213Medical Monitor (40HT513D)Lg Electronics.Inc2026-06-12590
K252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.2025-12-191080
K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.2025-10-29300
K252030RadiForce GX570; RadiForce GX570-AREizo Corporation2025-08-28590
K243221RadiForce RX570; RadiForce RX570-AREizo Corporation2024-11-27510
K243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.2024-10-25280
K242008Coronis OneLookBarco N.V.2024-08-02230
K2411053MP Color LCD Monitor (CL-S301)Jvckenwood Corporation2024-08-011010
K241441RadiForce RX670; RadiForce RX670-AREizo Corporation2024-07-16550
K24149921.3” 5MP Color LCD Display UMD5-21B01Acula Technology Corp.2024-06-13160
K23333621.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)Acula Technology Corp.2024-05-212350
K240310LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.2024-03-29560
K240130Medical Monitor (21HQ613D)Lg Electronics.Inc2024-02-15290
K2338975MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, Shenzhen Beacon Display Technology Co., Ltd.2024-02-06570
K233465RadiForce MX317WEizo Corporation2023-12-21580
K23298524HR513CLg Electronics.Inc2023-12-11800
K233693Nio Color 8MP (MDNC-8132)Barco N.V.2023-12-11240
K23102612MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z orShenzhen Beacon Display Technology Co., Ltd.2023-08-181290
K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc2023-08-15290
K230728JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/CNanjing Jusha Display Technology Co., Ltd.2023-06-09850
K231170C350/C350G LCD Monitor; M550/M550G LCD MonitorNanjing Jusha Display Technology Co., Ltd.2023-06-07430
K230723C510G/JUSHA-C510G/C510/JUSHA- C510 LCD MonitorNanjing Jusha Display Technology Co., Ltd.2023-05-18630
K230684RadiForce MX217Eizo Corporation2023-05-12600
K222719CX50NWide Corporation2023-05-092430
K222716MX50NWide Corporation2023-05-082420
K230643CP620G LCD monitor, CP620 LCD monitorNanjing Jusha Display Technology Co., Ltd.2023-05-01540
K23084532HL512D, 31HN713D, 32HQ713DLg Electronics.Inc2023-04-27300
K223768RadiForce RX270Eizo Corporation2023-04-201260
K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V.2023-03-21220
K22342332HQ713DLg Electronics.Inc2023-03-011070
K22378921HQ513DLg Electronics.Inc2023-01-09210
K2228648MP Color LCD Monitor CL-R813Jvckenwood Corporation2022-12-21900
K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DQingdao Hisense Medical Equipment Co., Ltd.2022-11-171150
K222132Hisense LCD monitor HMD2G21S, HMD3G21SQingdao Hisense Medical Equipment Co., Ltd.2022-11-081120
K222722CW60NWide Corporation2022-10-31530
K222717CL24NWide Corporation2022-10-31530
K222121C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitorNanjing Jusha Display Technology Co., Ltd.2022-09-19630
K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)Qingdao Hisense Medical Equipment Co., Ltd.2022-07-26560
K22106121HQ613DLg Electronics.Inc2022-06-03530
K221136RadiForce MX243WEizo Corporation2022-05-10210
K212231C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD MoniNanjing Jusha Display Technology Co., Ltd.2022-03-252520
K2129856MP Color LCD Monitor CL-S600Jvckenwood Corporation2021-12-16900
K21229521HQ513DLg Electronics.Inc2021-12-031340
K211491RadiForce RX370Eizo Corporation2021-07-12600
K20373312MP Color Digital Mammography LCD Monitor CL-S1200Jvckenwood Corporation2021-06-291900
K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation2021-04-23770
K210493CX30N (CX30PQX)Wide Corporation2021-04-14540
K210491CW120NWide Corporation2021-04-08480
K203106Nio Fusion 12MP (MDNC-12130)Barco N.V.2020-11-10260
K2023744MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+Shenzhen Beacon Display Technology Co., Ltd.2020-10-19610

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda