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510(k) K851875

KINNET by Kinetic Concepts, Inc. — Product Code INY

K851875 is an FDA 510(k) premarket notification submitted by Kinetic Concepts, Inc. for the device "KINNET". The FDA issued a decision of Substantially Equivalent on August 22, 1985. The device falls under product code INY (Bed, Patient Rotation, Manual), a Class I device regulated under 21 CFR 890.5180. Kinetic Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1985
Date Received
April 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Patient Rotation, Manual
Device Class
Class I
Regulation Number
890.5180
Review Panel
PM
Submission Type

Other clearances by Kinetic Concepts, Inc.

  • K050261 — V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (May 26, 2005)
  • K041642 — V.A.C. GRANUFOAM SILVER DRESSING (January 25, 2005)
  • K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (October 10, 2003)
  • K022011 — V.A.C. ABDOMINAL DRESSING (February 26, 2003)
  • K021500 — VACUUM ASSISTED CLOSURE (December 20, 2002)
  • K021501 — V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT (December 2, 2002)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K992448 — V.A.C. PLUS (January 18, 2000)
  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K972549 — SIMPULSE (November 18, 1997)

FDA data resources