Home / 510(k) Clearances / K052244

510(k) K052244

IISIS, VERSION 1.0 by Innovision Medical Technologies, LLC — Product Code MOD

K052244 is an FDA 510(k) premarket notification submitted by Innovision Medical Technologies, LLC for the device "IISIS, VERSION 1.0". The FDA issued a decision of Substantially Equivalent on October 13, 2005. 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 13, 2005
Date Received
August 17, 2005
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

Other clearances for product code MOD

  • K260051 — CorVision® (91-205-Z0014) (May 12, 2026)
  • 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)
  • K040712 — AIR SAFETY HEPA, MODEL 3500 (June 3, 2004)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)
  • K010401 — TRI-PLEX ADAPTER (October 30, 2002)
  • K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM (November 6, 2001)
  • K963633 — VENTNET; CENTRAL MONITORING STATION (December 16, 1996)

FDA data resources