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NatureSpirit BP-1307

by Simpro

NatureSpirit BP-1307 is a Class II device made by Simpro, cleared under FDA 510(k) K120554 on 10 Aug 2012 and listed in FDA GUDID since 28 Feb 2017 (UDI-DI 00897037001014), 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) K120554

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 Number00897037001014 UDI-DI Date28 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120554 Date10 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120554 decided 10 Aug 2012 Active
  • FDA GUDID UDI-DI 00897037001014 listed 28 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120554
  2. Listed FDA GUDID 00897037001014

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  • Withdrawn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
BP-1307
Primary DI / UDI-DI
00897037001014
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

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)