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Level 1 L1-CLAMP

by ICU Medical, Inc.

Level 1 L1-CLAMP is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K181699 on 26 Jul 2018 and listed in FDA GUDID since 9 Aug 2019 (UDI-DI 15019517100310), 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) K181699

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 Number15019517100310 UDI-DI Date9 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181699 Date26 Jul 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181699 decided 26 Jul 2018 Active
  • FDA GUDID UDI-DI 15019517100310 listed 9 Aug 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181699
  2. Listed FDA GUDID 15019517100310

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Level 1
Generic name
Frame/rail/pole device holder
Model / reference
L1-CLAMP
Primary DI / UDI-DI
15019517100310
510(k) Number
FDA product code
DWJ
GMDN term
Frame/rail/pole device holder
Device class
Class II
Regulation number
870.5900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Frame/rail/pole device holder

Cleared under the same submission (K181699)

and 3 more cleared under K181699

Similar devices in this category

Other devices filed under Frame/rail/pole device holder.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

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