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510(k) K810605

CHEMATIC BICARBONATE DIALYSATE SYSTEM by Trimedyne, Inc. — Product Code FKR

K810605 is an FDA 510(k) premarket notification submitted by Trimedyne, Inc. for the device "CHEMATIC BICARBONATE DIALYSATE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 1981. The device falls under product code FKR (Subsystem, Proportioning), a Class II device regulated under 21 CFR 876.5820. Trimedyne, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1981
Date Received
March 6, 1981
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 Trimedyne, Inc.

  • K053457 — VAPORMAX II (December 21, 2005)
  • K050412 — VAPORMAX (March 14, 2005)
  • K043012 — OMNIPULSE MINI, MODEL 2120 (November 17, 2004)
  • K041660 — TRIMEDYNE HOLMIUM LASER SYSTEMS (September 8, 2004)
  • K022655 — TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH (November 7, 2002)
  • K013974 — RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A (September 23, 2002)
  • K002308 — OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, (December 20, 2000)
  • K001676 — OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, (November 2, 2000)
  • K992574 — OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MO (October 29, 1999)
  • K992230 — OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP (July 12, 1999)

Other clearances for product code FKR

  • K140571 — NXSTAGE PUREFLOW SL (May 15, 2014)
  • K111174 — NXSTAGE PUREFLOW SL (September 19, 2011)
  • K080919 — NXSTAGE PUREFLOW SL (October 15, 2008)
  • 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)
  • 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