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Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets

by Zevex Inc. United States 510(k)

510(k) K242660 Product code FRN

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK242660 Date3 Oct 2024ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
FRN
Models / Variants
FDA applicant
Zevex, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Zevex Inc.

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K242660 24 fields · synced 22 Oct 2026