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510(k) K080919

NXSTAGE PUREFLOW SL by Nxstage Medical, Inc. — Product Code FKR

K080919 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NXSTAGE PUREFLOW SL". The FDA issued a decision of Substantially Equivalent on October 15, 2008. The device falls under product code FKR (Subsystem, Proportioning), a Class II device regulated under 21 CFR 876.5820. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2008
Date Received
April 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Proportioning
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Nxstage Medical, Inc.

  • K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (March 14, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K230632 — VersiHD with GuideMe software (August 11, 2023)
  • K183158 — NxStage Cartridge Express with Speedswap (August 9, 2019)
  • K181991 — NxStage Connected Health System (September 26, 2018)
  • K171331 — NxStage System One (August 24, 2017)
  • K170469 — NxStage System One Plus (May 9, 2017)
  • K150472 — NxStage System One (June 4, 2015)
  • K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge (March 20, 2015)
  • K141752 — NXSTAGE SYSTEM ONE (December 19, 2014)

Other clearances for product code FKR

  • K140571 — NXSTAGE PUREFLOW SL (May 15, 2014)
  • K111174 — NXSTAGE PUREFLOW SL (September 19, 2011)
  • K060296 — NXSTAGE DIALYSATE PREPARATION MODULE (March 31, 2006)
  • K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (March 17, 2005)
  • K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (June 4, 1985)
  • K850756 — AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (March 20, 1985)
  • K810605 — CHEMATIC BICARBONATE DIALYSATE SYSTEM (June 16, 1981)
  • K810127 — GAMBRO BICARBONATE MODULE, BCM-10 (February 25, 1981)
  • K802465 — BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (November 12, 1980)
  • K800772 — MOD. DM-357 BICARBONATE RETROFIT KIT (May 14, 1980)

FDA data resources