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FondCircle M1

by FondCircle Inc.

FondCircle M1 is a Class II device made by FondCircle Inc., cleared under FDA 510(k) K191657 on 20 Mar 2020 and listed in FDA GUDID since 14 Mar 2025 (UDI-DI 00850070979238), 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) K191657

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 Number00850070979238 UDI-DI Date14 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK191657 Date20 Mar 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191657 decided 20 Mar 2020 Active
  • FDA GUDID UDI-DI 00850070979238 listed 14 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191657
  2. Listed FDA GUDID 00850070979238

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
FondCircle
Generic name
Glucose monitoring system IVD, home-use
Model / reference
M1
Primary DI / UDI-DI
00850070979238
510(k) Number
FDA product code
NBW
GMDN term
Glucose monitoring system IVD, home-use
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose monitoring system IVD, home-use

Cleared under the same submission (K191657)

and 8 more cleared under K191657

Similar devices

Other devices filed under FDA product code NBW (System, Test, Blood Glucose, Over The Counter).

Other devices from FondCircle Inc.

See all devices from FondCircle Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)