Home / 510(k) Clearances / K843442

510(k) K843442

URINARY DRAINAGE CONTAINER 2013 WITH by Vital Metrics, Inc. — Product Code FFG

K843442 is an FDA 510(k) premarket notification submitted by Vital Metrics, Inc. for the device "URINARY DRAINAGE CONTAINER 2013 WITH". The FDA issued a decision of Substantially Equivalent on January 3, 1985. The device falls under product code FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable), a Class II device regulated under 21 CFR 876.1800. Vital Metrics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
September 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances by Vital Metrics, Inc.

  • K883201 — VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS (September 26, 1988)
  • K882956 — VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION (August 3, 1988)
  • K844973 — IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES (March 18, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K840917 — URINARY MONITORING SYS 240 (May 1, 1984)
  • K834448 — URINARY DRAINAGE CONTAINER (February 10, 1984)
  • K832526 — UROTRACK PLUS (September 19, 1983)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)

Other clearances for product code FFG

  • K893827 — PEAK FLOW RATE METER (August 11, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K850169 — ERIS URO-DIAGNOSTIC SYSTEM (April 22, 1985)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K843224 — UROPUMP MODEL 1711 (October 19, 1984)
  • K833043 — UROMETER (February 4, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)
  • K813082 — UREOFIX 500 URINE MEASURING SYSTEM (December 31, 1981)

FDA data resources