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510(k) K013928

PAIN CARE 3200 by Breg, Inc. — Product Code MEB

K013928 is an FDA 510(k) premarket notification submitted by Breg, Inc. for the device "PAIN CARE 3200". The FDA issued a decision of Substantially Equivalent on December 3, 2001. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Breg, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2001
Date Received
November 28, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Breg, Inc.

  • K183702 — Polar Care Wave (March 1, 2019)
  • K070402 — MODIFICATION TO POLAR CARE 500 (March 29, 2007)
  • K041714 — E-PAIN CARE (October 1, 2004)
  • K020988 — PAIN CARE 4200 (April 4, 2002)
  • K003611 — PAIN CARE MULTI-PORT CATHETER, MODEL 2000L (December 13, 2000)
  • K002073 — PAIN CARE 3000 (September 19, 2000)
  • K002321 — PAIN CARE 2000L (August 14, 2000)
  • K983454 — PAIN CARE 2000 (December 16, 1998)
  • K963596 — POLAR CARE 300 (December 4, 1996)
  • K961855 — POLAR CARE (MODEL 500/50000) (August 9, 1996)

Other clearances for product code MEB

  • K250234 — SMARTeZ™ Elastomeric Infusion Pump (RS series) (April 24, 2026)
  • K240624 — InfuLife (November 5, 2024)
  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K151650 — SMARTez elastomeric infusion pump (April 4, 2016)
  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)

FDA data resources