Skip to content

Rotem Delta Thromboelastometry System

by Pentapharm GmbH

510(k) K083842

Rotem Delta Thromboelastometry System is a Class II device made by Pentapharm GmbH, cleared under FDA 510(k) K083842 on 23 Mar 2010, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083842 Date23 Mar 2010ClearedStatusActive

Official records

Recalls

2 recalls · FDA

    • Terminated Z-1090-2016 FDA Class II initiated 18 Feb 2016 on shared 510(k) K083842

    Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.

    • Terminated Z-1379-2015 FDA Class II initiated 23 Oct 2014

    Some of vials were found to be partially filled.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K083842
  2. Recall initiated FDA recalls Z-1379-2015
  3. Recall initiated FDA recalls Z-1090-2016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JPA
Device class
Class II
Regulation
21 CFR Part 864.5425
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K083842

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K083842
UDI-DISize and differences
ROTEM® delta System
Tem Innovations GmbH
200100-US / delta System04260160470020 —On the market
ROTEM® delta System (US/CA)
Tem Innovations GmbH
201001 / delta System (US/CA)04260160470587 —On the market
ROTEM® hep-tem®
Tem Innovations GmbH
503-09-US / hep-tem®04260160470082 —On the market
ROTEM® in-tem®
Tem Innovations GmbH
503-02-US / in-tem®04260160470044 —On the market
ROTEM® ROTROL N
Tem Innovations GmbH
503-24-US, 503-24 / ROTROL N04260160470105 —On the market
ROTEM® ROTROL P
Tem Innovations GmbH
503-25-US, 503-25 / ROTROL P04260160470112 —On the market
ROTEM® star-tem® 20
Tem Innovations GmbH
503-10-US / star-tem® 2004260160470099 —On the market

Similar devices

Other devices filed under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies).