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510(k) K780209

DILUTION SPIKE by Sterling Drug, Inc. — Product Code FMI

K780209 is an FDA 510(k) premarket notification submitted by Sterling Drug, Inc. for the device "DILUTION SPIKE". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sterling Drug, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
February 6, 1978
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 Sterling Drug, Inc.

  • K901369 — GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II (June 5, 1990)
  • K896110 — BIOBRANE(R) II (November 28, 1989)
  • K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
  • K840260 — PERIOGRAF DURAPATITE 40-60 MESH (April 5, 1984)
  • K820023 — CONAGRAF TM DURAPATITE CONES (February 24, 1982)
  • K820164 — EMPTY STERILE CARPUJECT (February 24, 1982)
  • K813257 — ALVEOGRAF DURAPATITE(18-40 MESH) (January 5, 1982)
  • K813070 — PERIOGRAF (November 20, 1981)

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