Skip to content

TRUEplus

by Trividia Health, Inc. 37 variants

TRUEplus is a Class II device made by Trividia Health, Inc., cleared under FDA 510(k) K993017 on 25 Feb 2000 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00021292005832), active as of 23 Oct 2026. 8 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

510(k) K993017

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00021292005832 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK993017 Date25 Feb 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K993017 decided 25 Feb 2000 Active
  • FDA GUDID UDI-DI 00021292005832 listed 20 Sep 2016 Listed

Recalls

8 recalls · FDA

    • Terminated Z-0119-2019 FDA Class II initiated 4 Sep 2018

    Small hole at the end of the syringe is impeding suction of liquid.

    • Terminated Z-3202-2018 FDA Class II initiated 24 Aug 2018

    Defect consists of a small crack in the top end of the barrel near the needle.

    • Terminated Z-0572-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009

    Needles are becoming dislodged from the barrels

  • 5 recalls, same reason

    • Terminated Z-0573-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0570-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0569-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0574-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0571-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009

    Needles are becoming dislodged from the barrels.

Timeline

10 dated events

  1. Cleared FDA 510(k) K993017
  2. Recall initiated FDA recalls Z-0572-2010
  3. Recall initiated FDA recalls Z-0573-2010
  4. Recall initiated FDA recalls Z-0570-2010
  5. Recall initiated FDA recalls Z-0569-2010
  6. Recall initiated FDA recalls Z-0574-2010
  7. Recall initiated FDA recalls Z-0571-2010
  8. Listed FDA GUDID 00021292005832
  9. Recall initiated FDA recalls Z-3202-2018
  10. Recall initiated FDA recalls Z-0119-2019

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Insulin syringe/needle, basic
Model / reference
TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.3cc insulin
Primary DI / UDI-DI
00021292005832
510(k) Number
FDA product code
FMF
GMDN term
Insulin syringe/needle, basic
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Length — 0.31 Inch
Total Volume — 0.3 Milliliter
Needle Gauge — 30 Gauge

Related devices

Category: Insulin syringe/needle, basic

Cleared under the same submission (K993017)

and 8 more cleared under K993017

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from Trividia Health, Inc.

See all devices from Trividia Health, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)