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510(k) K011125

NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI by Hudson Respiratory Care, Inc. — Product Code CAT

K011125 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI". The FDA issued a decision of Substantially Equivalent on June 13, 2001. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Hudson Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2001
Date Received
April 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5340
Review Panel
AN
Submission Type

Other clearances by Hudson Respiratory Care, Inc.

  • K031383 — MODEL 780 (July 7, 2003)
  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K010402 — SMOOTH-FLO CIRCUIT (March 14, 2001)
  • K001213 — CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, (November 3, 2000)
  • K993355 — HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-4 (May 24, 2000)
  • K994352 — SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 (March 22, 2000)
  • K964719 — HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR (February 21, 1997)
  • K961150 — DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA (September 10, 1996)
  • K961914 — BACTERIA/VIRAL FILTER (August 14, 1996)
  • K955645 — CATH-GUIDE (March 12, 1996)

Other clearances for product code CAT

  • K935533 — NASAL CANNULA (February 3, 1994)
  • K922397 — 4 SURE TM NASAL OXYGEN CANNULA (March 18, 1993)
  • K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED (August 14, 1992)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K912197 — SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (August 20, 1991)
  • K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA (July 24, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K896036 — THE COMFORTABLE CANNULA (November 17, 1989)
  • K892435 — KENDALL CURITY OXYGEN NASAL CANNULA (June 12, 1989)

FDA data resources