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FondCircle IK

by FondCircle Inc.

FondCircle IK is a Class II device made by FondCircle Inc., listed in FDA GUDID since 6 Apr 2025 (UDI-DI 00850070979283), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850070979283 UDI-DI Date6 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
FondCircle
Generic name
Blood lancing device tip
Model / reference
IK
Primary DI / UDI-DI
00850070979283
FDA product code
QRL
GMDN term
Blood lancing device tip
Device class
Class II
Regulation number
878.4850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood lancing device tip

Similar devices

Other devices filed under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).

Other devices from FondCircle Inc.

See all devices from FondCircle Inc. →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)