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Jelco 4139

by ICU Medical, Inc.

Jelco 4139 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K946289 on 10 Jul 1995 and listed in FDA GUDID since 5 Jul 2017 (UDI-DI 10351688041852), active as of 23 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 23 Oct 2026

Documents

510(k) K946289

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 Number10351688041852 UDI-DI Date5 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK946289 Date10 Jul 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K946289 decided 10 Jul 1995 Active
  • FDA GUDID UDI-DI 10351688041852 listed 5 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K946289
  2. Listed FDA GUDID 10351688041852

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Jelco
Generic name
Needle guard
Model / reference
4139
Primary DI / UDI-DI
10351688041852
510(k) Number
FDA product code
FMI
GMDN term
Needle guard
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Needle guard

Cleared under the same submission (K946289)

Similar devices

Other devices filed under FDA product code FMI (Needle, hypodermic, single lumen).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

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