Six upper-arm automatic blood pressure monitors from Joytech Healthcare's DBP Plus series have been granted FDA 510(k) clearance under K261394, enabling commercialization in the U.S. market.
For healthcare brands and distributors active in the U.S. market, this clearance is more than a regulatory milestone — it is a practical market-entry enabler. Each cleared device has been reviewed as a Class II medical device and found substantially equivalent to legally marketed predicates, with an intended use covering the general population.
A Cleared Lineup of Six New Models
The DBP Plus series brings six new models into Joytech Healthcare's U.S.-cleared portfolio: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, and DBP-62E2B Plus.
Each model is a fully automatic upper-arm blood pressure monitor built for daily home measurement. The series also continues a proven regulatory lineage — its predecessors DBP-6186 and DBP-6286B were cleared by FDA in 2025 for users with larger arms, and the Plus generation extends that same engineering platform to a broader model range.
Two Cuff Sizes, Wider User Coverage
Every model in the batch is configured with one of two cuff options — a standard 22–42 cm cuff or an extended 40–56 cm large arm cuff.
This dual-cuff approach matters commercially as much as clinically. It allows retail programs and institutional buyers to build size-inclusive assortments from a single cleared product family, so that adults whose arms fall outside standard cuff ranges are no longer forced into compromise measurements.
Where These Monitors Fit in a U.S. Portfolio
For buyers evaluating the DBP Plus series, three points stand out:
The full six-model batch is covered by one FDA 510(k) clearance, so assortment planning can proceed without per-model regulatory gaps.
Both standard and large arm cuff versions are available within the cleared scope.
The general population indication supports a broad range of U.S. distribution opportunities, including retail, e-commerce, and other healthcare channels.
The clearance record itself can be verified by partners during due diligence — the K261394 summary is publicly accessible through the FDA database.
Built on an Established Regulatory Track Record
This round of clearances adds to a growing U.S. compliance portfolio at Joytech Healthcare, which already includes prior 510(k) clearances for blood pressure monitors and blood glucose monitoring systems, alongside CE marking under the EU MDR, ISO 13485 certification, and MDSAP compliance.
For OEM/ODM partners, that track record shortens the compliance conversation: the question shifts from whether the manufacturer can meet U.S. requirements to which model configuration fits the program.
Available for Distribution and OEM/ODM Programs
Joytech Healthcare is currently accepting inquiries from U.S. medical device distributors, importers, and brand partners interested in the DBP Plus series — including private-label development, custom packaging, and documentation support for market registration.
About Joytech Healthcare
Joytech Healthcare is a professional manufacturer of home healthcare and medical monitoring devices, specializing in blood pressure monitors, thermometers, pulse oximeters, nebulizers, breast pumps and other healthcare products.
We provide OEM/ODM medical device solutions for global healthcare brands, distributors, and partners, focusing on regulatory compliance, product reliability, and long-term cooperation.
To request evaluation samples, clearance documentation, or a quotation for the DBP Plus series, reach our team at sale14@sejoy.com— or browse the full FDA 510(k) cleared blood pressure monitor lineup on our website.
