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NatureSpirit KD-5904

by Simpro

NatureSpirit KD-5904 is a Class II device made by Simpro, cleared under FDA 510(k) K070826 on 15 Aug 2007 and listed in FDA GUDID since 24 Feb 2017 (UDI-DI 00897037001038), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K070826

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00897037001038 UDI-DI Date24 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070826 Date15 Aug 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070826 decided 15 Aug 2007 Active
  • FDA GUDID UDI-DI 00897037001038 listed 24 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070826
  2. Listed FDA GUDID 00897037001038

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NatureSpirit
Generic name
Automatic-inflation electronic sphygmomanometer, portable, finger
Model / reference
KD-5904
Primary DI / UDI-DI
00897037001038
510(k) Number
FDA product code
DXN
GMDN term
Automatic-inflation electronic sphygmomanometer, portable, finger
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Automatic-inflation electronic sphygmomanometer, portable, finger

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from Simpro

See all devices from Simpro →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)