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510(k) K953485

SIMS CPAP SYSTEM by Smiths Industries Medical Systems, Inc. — Product Code BYE

K953485 is an FDA 510(k) premarket notification submitted by Smiths Industries Medical Systems, Inc. for the device "SIMS CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 26, 1995. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Smiths Industries Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1995
Date Received
July 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

Other clearances by Smiths Industries Medical Systems, Inc.

  • K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED (January 20, 1998)
  • K965017 — REGIONAL ANESTHESIA TRAYS (March 14, 1997)
  • K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE (January 17, 1997)
  • K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT (October 21, 1996)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. IN (May 2, 1996)
  • K953483 — SIMS BLUE LINE ENDOBRONCHIAL TUBE (October 24, 1995)
  • K932947 — WALLACE Y-CAN (September 1, 1995)
  • K932946 — WALLACE IV CANNULA (September 1, 1995)
  • K952516 — PRO-VENT, LINE DRAW, PULSATOR (July 14, 1995)

Other clearances for product code BYE

  • K160112 — Besmed PEEP Valve (April 29, 2016)
  • K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (April 14, 2014)
  • K133210 — B&B BUBBLER (March 28, 2014)
  • K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (August 5, 2013)
  • K112546 — O_TWO CPAP SYSTEM (December 27, 2011)
  • K110713 — WATERPAP VALVE (September 12, 2011)
  • K103833 — NEOPIP PATIENT CIRCUIT WITH PEEP (April 20, 2011)
  • K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (August 6, 2010)
  • K090710 — MERCURY CPAP (August 20, 2009)
  • K090317 — BABI*PLUS BUBBLE PAP VALVE (May 20, 2009)

FDA data resources