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510(k) K853971

REGULATOR-INHALATOR SYSTEM by Stephenson Industries, Inc. — Product Code BTL

K853971 is an FDA 510(k) premarket notification submitted by Stephenson Industries, Inc. for the device "REGULATOR-INHALATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 9, 1985. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Stephenson Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1985
Date Received
September 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Stephenson Industries, Inc.

  • K963777 — HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 (July 28, 1997)
  • K861593 — TOPICAL HYPERBARIC OXYGEN CHAMBER (May 12, 1986)
  • K861101 — THE NEW FLEXIBLE COLLAPSIBLE CHAMBER (May 6, 1986)

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)

FDA data resources