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Aria FB201B

by Fitbit LLC

Aria FB201B is a Class II device made by Fitbit LLC, cleared under FDA 510(k) K133872 on 2 Jun 2014 and listed in FDA GUDID since 21 Oct 2016 (UDI-DI 00898628002045), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K133872

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 Number00898628002045 UDI-DI Date21 Oct 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133872 Date2 Jun 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133872 decided 2 Jun 2014 Active
  • FDA GUDID UDI-DI 00898628002045 listed 21 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133872
  2. Listed FDA GUDID 00898628002045

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aria
Generic name
Bioelectrical body composition analyser
Model / Ref / Catalog
FB201B
Primary DI / UDI-DI
00898628002045
510(k) Number
FDA product code
MNW
GMDN term
Bioelectrical body composition analyser
Device class
Class II
Regulation number
870.2770
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code MNW (Analyzer, Body Composition).

Other devices from Fitbit LLC

See all devices from Fitbit LLC →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)