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510(k) K003382

SARSTEDT NEEDLE PROTECTOR by Sarstedt, Inc. — Product Code FMI

K003382 is an FDA 510(k) premarket notification submitted by Sarstedt, Inc. for the device "SARSTEDT NEEDLE PROTECTOR". The FDA issued a decision of Substantially Equivalent on March 30, 2001. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sarstedt, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2001
Date Received
October 31, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Sarstedt, Inc.

  • K051019 — SAFETY NEEDLE (July 25, 2005)
  • K031359 — S-MONOVETTE EDTA K2-GEL (September 12, 2003)
  • K032150 — SAFETY-MULTIFLY (September 12, 2003)
  • K024237 — URINE MONOVETTE BORIC ACID (April 14, 2003)
  • K913622 — HEMOPLUS (January 31, 1992)

Other clearances for product code FMI

  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)

FDA data resources