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510(k) K983750

DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER by Deroyal Industries, Inc. — Product Code FMI

K983750 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER". The FDA issued a decision of Substantially Equivalent on November 30, 1998. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1998
Date Received
October 23, 1998
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

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  • K171475 — DeRoyal Laprador Specimen Retrieval System (August 17, 2017)
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  • 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