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510(k) K880161

ACKRAD PEDIATRIC C.P.A.P. SYSTEM by Ackrad Laboratories — Product Code BYE

K880161 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "ACKRAD PEDIATRIC C.P.A.P. SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1988. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Ackrad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1988
Date Received
January 13, 1988
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 Ackrad Laboratories

  • K021272 — SIB CATHETER, MODEL 61-7005 (May 21, 2002)
  • K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TR (April 24, 2002)
  • K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (April 16, 2002)
  • K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (April 9, 1997)
  • K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 8, 1996)
  • K952542 — ACKRAD ESOPHAGEAL BALLOON CATHETER SET (April 23, 1996)
  • K940176 — ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION (April 23, 1996)
  • K953034 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 29, 1995)
  • K915813 — ACKRAD ERCP CONTRAST DELIVERY SET (March 11, 1992)
  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)

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