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510(k) K160112

Besmed PEEP Valve by Besmed Health Business Corp — Product Code BYE

K160112 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "Besmed PEEP Valve". The FDA issued a decision of Substantially Equivalent on April 29, 2016. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2016
Date Received
January 19, 2016
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 Besmed Health Business Corp

  • K241339 — Besmed Bacterial Filter and HMEF (November 14, 2024)
  • K172804 — Besmed Peak Flow Meter (January 11, 2018)
  • K150591 — Besmed Reusable Jet Nebulizer (June 30, 2015)
  • K143150 — CO2 monitoring line with and without in-line filter (February 5, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K133873 — TRIBALL INCENTIVE SPIROMETER (April 4, 2014)
  • K091272 — BESMED JET NEBULIZER BOTTLE SET (November 10, 2009)
  • K031374 — BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 (November 28, 2003)
  • K031375 — BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 (November 20, 2003)

Other clearances for product code BYE

  • 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)
  • K081266 — MERCURY MEDICAL PEEP VALVE (March 5, 2009)

FDA data resources