Fuzzy Type Digital Blood Pressure Monitor HD-1000S & HD-2000F

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Fuzzy Type Digital Blood Pressure Monitor, Model #'s Hd-1000S & Hd-2000F

510(k) Number

K983855 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)

  Class II

  FDA 510(k) K092432 Active Cleared 9 Oct 2009

• Digital Blood Pressure Monitor, Models Hd-503 and Hd-505

  Class II

  FDA 510(k) K002722 Active Cleared 11 Sep 2000

• Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5

  Class II

  FDA 510(k) K053556 Active Cleared 31 Aug 2006

• Body Composition Analyzer

  Class II

  FDA 510(k) K140045 Active Cleared 18 Feb 2015

• Non-Invasive Blood Pressure Monitor, Models Ft-500R/L and Ft-700R/L

  Class II

  FDA 510(k) K062462 Active Cleared 29 Sep 2006

• Automatic Blood Pressure Monitor

  Class II

  FDA 510(k) K140762 Active Cleared 2 Jul 2015

See all devices from Jawon Medical Co., Ltd. →

• Are these blood pressure monitors meant for one-time use or can they be reused in a clinical setting?

  The Jawon Medical Co., Ltd. Fuzzy Type Digital Blood Pressure Monitors (HD-1000S & HD-2000F) are explicitly labeled as reusable medical instruments in the regulatory data. Since no sterility or single-use designation is specified, they are intended for repeated use in clinical or home settings, provided proper cleaning and maintenance protocols are followed.

• What types of blood pressure measurements do these devices provide, and how do they work?

  These monitors are non-invasive, oscillometric sphygmomanometers, meaning they measure blood pressure by detecting oscillations in the cuff as it inflates and deflates automatically. They provide systolic and diastolic pressure readings via microprocessor-controlled inflation/deflation, making them suitable for both clinical and home use without manual adjustments.

• What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this device?

  The Fuzzy Type Digital Blood Pressure Monitor (HD-1000S & HD-2000F) received FDA 510(k) clearance (K983855) under the Traditional 510(k) review pathway, determined to be substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, and the device falls under product code DXN (Class II, Special Controls).

• Are there multiple models available, and if so, how do they differ?

  Yes, there are two models: the HD-1000S and the HD-2000F. While the regulatory data does not specify functional differences, the naming convention suggests potential variations in features (e.g., display, connectivity, or additional metrics). Both share the same oscillometric measurement principle and reusable design, so compatibility with clinical workflows would depend on specific clinical needs.