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510(k) K843882

TRENDS LANCET by Orange Medical Instruments, Inc. — Product Code KMK

K843882 is an FDA 510(k) premarket notification submitted by Orange Medical Instruments, Inc. for the device "TRENDS LANCET". The FDA issued a decision of Substantially Equivalent on November 5, 1984. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Orange Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1984
Date Received
October 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type

Other clearances by Orange Medical Instruments, Inc.

  • K860808 — CONTINUCATH (March 13, 1986)
  • K851822 — BETA SCAN TRENDS METER (October 3, 1985)
  • K844796 — MICRO-BETA U100 SYRINGE (December 18, 1984)
  • K841369 — BETA SCAN DRYSTIX (August 23, 1984)
  • K833705 — BETAJECT BD U100 (May 9, 1984)
  • K833706 — CLICK-COUNT U100 INSULIN SYRINGE (April 5, 1984)
  • K832691 — BETA SCAN REAGENT STRIP (November 14, 1983)
  • K832793 — NEOCATH 1000 W/HEPCOTE (September 26, 1983)
  • K831897 — BETA I PROGRAMMABLE INFUSION PUMP (August 12, 1983)
  • K831523 — BETA SCAN NORMAL CONTROL SOLUTION (July 19, 1983)

Other clearances for product code KMK

  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec (July 9, 2019)
  • K981860 — A P HARNESS (June 3, 1999)
  • K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER (October 11, 1996)
  • K941098 — SECURE-SITE (August 9, 1995)
  • K943147 — STATLOCK CV (September 29, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE (July 14, 1994)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K935389 — CONMED VENI-GARD I.V. DRESSING (March 7, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (February 18, 1994)

FDA data resources