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510(k) K022062

IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 by Impact Instrumentation, Inc. — Product Code MOD

K022062 is an FDA 510(k) premarket notification submitted by Impact Instrumentation, Inc. for the device "IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00". The FDA issued a decision of Substantially Equivalent on May 6, 2003. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Impact Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2003
Date Received
June 25, 2002
Clearance Type
Abbreviated
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 by Impact Instrumentation, Inc.

  • K133196 — IMPACT MODEL 323 ASPIRATOR (March 10, 2014)
  • K111473 — UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR (February 16, 2012)
  • K103318 — UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR (April 7, 2011)
  • K091238 — UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ (August 13, 2009)
  • K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV (December 10, 2008)
  • K051476 — UNI-VENT MODEL 73X (October 28, 2005)
  • K032386 — UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) (March 26, 2004)
  • K951423 — ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT (April 18, 1995)
  • K941096 — ELECTRIC VACUM PUMP (January 5, 1995)
  • K931473 — IMPACT MODEL 753 (December 30, 1994)

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)
  • K052244 — IISIS, VERSION 1.0 (October 13, 2005)
  • K040712 — AIR SAFETY HEPA, MODEL 3500 (June 3, 2004)
  • 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