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Ultraflo-V 607

by Innovative Medical Technologies, Inc.

Ultraflo-V 607 is a Class II device made by Innovative Medical Technologies, Inc., cleared under FDA 510(k) K172763 on 4 Jun 2018 and listed in FDA GUDID since 13 Feb 2025 (UDI-DI 00857182006203), 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) K172763

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 Number00857182006203 UDI-DI Date13 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK172763 Date4 Jun 2018IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172763 decided 4 Jun 2018 Active
  • FDA GUDID UDI-DI 00857182006203 listed 13 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172763
  2. Listed FDA GUDID 00857182006203

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ultraflo-V
Generic name
Blood collection tube holder/needle
Model / Ref / Catalog
607
Primary DI / UDI-DI
00857182006203
510(k) Number
FDA product code
FMI
GMDN term
Blood collection tube holder/needle
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).

Other devices from Innovative Medical Technologies, Inc.

See all devices from Innovative Medical Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)