510(k) K252685

Device: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
Applicant: Joytech Healthcare Co. , Ltd.
510(k) number: K252685
Product code: DXN
Decision: Substantially Equivalent (SESE)
Decision date: 2026-02-13
Date received: 2025-08-26
Regulation: 870.1130
Classification name: System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Jing Cong
Address: #365, Wuzhou Rd. #502, Shunda Rd. Hangzhou CN 311100 311100

FDA Registration Numbers

3015181391
3003993690
1423537
3042928308
3006636961
3022028624
3001744144
3033482477
3006441164
3003074886
3033530347
3007499349
3038613041
1066270
3003703880
3010288146
3026753375
3015997711
9681377
3015522053
3017887928
3013596024
3013500228
9610816
9680215
3013053058
3003829675
3015697152
3009690509
3009673645
3015109923
3021635975
3022147580
9617543
3008483389
3008167616
3004832480
3009617411
3013826848
3013426279
8030978
3008164770
1450057
3016931915
3007413079
8010482
3021611414
3016719957
3010838917
1422443
3018008670
3030733800
8043510
3004415095
3005798905
1651104
3011420269
3003971136
3012104670
3011200896
3001149827
3010381606
3021559257
3038598497
3004727093
3010536822
2412762
3011353843
9617127
3032109181
3000126629
3004145393
1066444
3015967131
1319390
3008925277
3015455735
1713468
1054713

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DXN

510(k)	Device	Applicant	Decision date
K253570	Blood Pressure Monitor (W06LT)	Shenzhen Jamr Technology Co., Ltd.	2026-05-20
K254048	Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)	Shenzhen Urion Technology Co., Ltd.	2026-05-14
K253152	BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)	Biozen, LLC	2026-05-06
K260260	Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)	Honsun (Nantong) Co., Ltd.	2026-04-28
K252501	Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)	Joytech Healthcare Co. , Ltd.	2026-04-28
K253982	Korotkoff sound blood pressure monitor	Beijing Hanvon Health Technology Co., Ltd.	2026-04-21
K260276	Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro	Shenzhen AOJ Medical Technology Co., Ltd.	2026-04-01
K254225	Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)	Shenzhen HanHan Technology Co., Ltd.	2026-04-01
K260273	Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)	Shenzhen Urion Technology Co., Ltd.	2026-03-26
K252779	YUWELL® Electronic Blood Pressure Monitor (YE630CR)	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	2026-03-05
K253228	YUWELL® Electronic Blood Pressure Monitor (YE650AR)	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	2026-02-23
K253133	Wrist Blood Pressure Monitor (BPM-W1VL)	Shenzhen Imdk Medical Technology Co., Ltd.	2026-02-13
K251581	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	Shenzhen Hingmed Medical Instrument Co., Ltd.	2026-02-13
K251307	Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)	Shenzhen Hingmed Medical Instrument Co., Ltd.	2026-01-12
K253142	Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)	Ningbo Ranor Medical Technology Co., Ltd.	2026-01-09