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510(k) K944880

BODILY FLUID DISPOSAL KIT by Clinical Resources, Inc. — Product Code FXX

K944880 is an FDA 510(k) premarket notification submitted by Clinical Resources, Inc. for the device "BODILY FLUID DISPOSAL KIT". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Clinical Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
October 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Clinical Resources, Inc.

  • K941470 — TRACHEOSTOMY CARE KIT (February 14, 1995)
  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K944881 — SKIN SCRUB TRAY (December 27, 1994)
  • K945019 — FLUFF GAUXZE ROLL (December 23, 1994)
  • K945021 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K944879 — GAUZE SPONGES (December 23, 1994)
  • K945020 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K941469 — IV START KIT (May 12, 1994)
  • K941467 — WOUND DRESSING KIT (May 12, 1994)
  • K941471 — CENTRAL LINE DRESSING CHANGE TRAY (May 12, 1994)

Other clearances for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT (March 18, 2026)
  • K252534 — Surgical Face Mask (Ear mount) (March 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (February 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)

FDA data resources