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510(k) K010401

TRI-PLEX ADAPTER by The Medical Device Group, Inc. — Product Code MOD

K010401 is an FDA 510(k) premarket notification submitted by The Medical Device Group, Inc. for the device "TRI-PLEX ADAPTER". The FDA issued a decision of Substantially Equivalent on October 30, 2002. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2002
Date Received
February 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory To Continuous Ventilator (Respirator)
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • K242485 — EveryWare (May 20, 2025)
  • K161411 — Care Cycle Connect Application (February 17, 2017)
  • K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (August 14, 2009)
  • K052751 — VENTLINK SYSTEM (December 23, 2005)
  • K052244 — IISIS, VERSION 1.0 (October 13, 2005)
  • K040712 — AIR SAFETY HEPA, MODEL 3500 (June 3, 2004)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)

FDA data resources