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510(k) K910257

BAXA PCA INFUSOR by Baxa Corp., Sub. of Cook Group, Inc. — Product Code MEA

K910257 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "BAXA PCA INFUSOR". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
January 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Pca
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Baxa Corp., Sub. of Cook Group, Inc.

  • K903159 — VALVE CONTROLLER FOR MICROMACRO COMPOUNDER (November 7, 1990)
  • K904225 — KWIKMIX (November 5, 1990)
  • K900585 — TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP (April 18, 1990)
  • K873875 — BAXA EXACTA-MED PHARMACY PUMP (November 24, 1987)
  • K872743 — BAXA TUBING SETS (FOR PHARMACY PUMP) (October 9, 1987)
  • K844904 — CYTOSAFE NEEDLE (February 22, 1985)
  • K832347 — TWOFER NEEDLE (September 12, 1983)
  • K832312 — I.V. TRANSFER NEEDLE (September 12, 1983)
  • K832332 — VENTED I.V. TRANSFER NEEDLE (September 12, 1983)
  • K832254 — BAXA ADDISEAL (July 26, 1983)

Other clearances for product code MEA

  • K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Inte (August 29, 2017)
  • K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis I (August 24, 2017)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (December 9, 2013)
  • K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (November 4, 2009)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR (July 15, 2005)
  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTE (December 6, 2004)
  • K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (October 18, 2004)

FDA data resources