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510(k) K950861

RECONSTITUTION ACCESSOREIS by Organon, Inc. — Product Code FPK

K950861 is an FDA 510(k) premarket notification submitted by Organon, Inc. for the device "RECONSTITUTION ACCESSOREIS". The FDA issued a decision of Substantially Equivalent on May 26, 1995. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Organon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1995
Date Received
February 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Organon, Inc.

  • K253642 — Jada System (Jada-2002) (May 15, 2026)
  • K853388 — MONOSTICON UNI-DOT (August 22, 1985)
  • K842314 — DUOCLON COLOR-CEPT (August 24, 1984)
  • K841525 — OREIA II B-HCG PREGNANCY TEST KIT (June 5, 1984)
  • K841602 — ACCURATE BETA 30 PREGNANCY TEST KIT (May 22, 1984)
  • K840650 — B-NEOCEPT 30 (April 4, 1984)
  • K832801 — OREIA II B-HCG, ENZYME INNUNOASSAY (December 8, 1983)
  • K831339 — NEO-PREGNOSTICON DUOCLON TUBE TEST (June 8, 1983)
  • K831109 — DUOCLON SLIDE TEST (June 2, 1983)
  • K823682 — BETA FFIRM TEST (January 7, 1983)

Other clearances for product code FPK

  • K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (August 2, 2013)
  • K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (February 9, 2007)
  • K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, (December 11, 2006)
  • K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 (November 29, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET (July 11, 2003)
  • K022431 — MEDRAD TRANSFER SET (September 5, 2002)
  • K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128 (February 26, 1997)
  • K953864 — SILCLEAR TUBING (MODIFICATION) (November 6, 1995)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)

FDA data resources