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510(k) K051985

BIOVALVE MINI-JECT NEEDLEFREE INJECTOR by Biovalve Technologies, Inc. — Product Code KZE

K051985 is an FDA 510(k) premarket notification submitted by Biovalve Technologies, Inc. for the device "BIOVALVE MINI-JECT NEEDLEFREE INJECTOR". The FDA issued a decision of Substantially Equivalent on August 17, 2005. The device falls under product code KZE (Injector, Fluid, Non-Electrically Powered), a Class II device regulated under 21 CFR 880.5430. Biovalve Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2005
Date Received
July 22, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

Other clearances by Biovalve Technologies, Inc.

  • K050971 — BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) (August 16, 2005)
  • K032976 — BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 (April 16, 2004)

Other clearances for product code KZE

  • K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (July 19, 2012)
  • K111517 — PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJE (July 27, 2011)
  • K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (March 2, 2011)
  • K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (December 24, 2009)
  • K090003 — ZETAJET (April 2, 2009)
  • K081532 — PHARMAJET NEEDLE-FREE INJECTION SYSTEM (February 26, 2009)
  • K082138 — AIRGENT, MODEL AG7000010 (January 23, 2009)
  • K060819 — COOL.CLICK 2 (June 16, 2006)
  • K050734 — COOL.CLICK (June 3, 2005)
  • K041239 — GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 (November 8, 2004)

FDA data resources