Home / 510(k) Clearances / K920398

510(k) K920398

CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT by Medi-Flex Hospital Products, Inc. — Product Code FMF

K920398 is an FDA 510(k) premarket notification submitted by Medi-Flex Hospital Products, Inc. for the device "CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT". The FDA issued a decision of Substantially Equivalent on April 15, 1992. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Medi-Flex Hospital Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1992
Date Received
January 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Medi-Flex Hospital Products, Inc.

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • K962740 — DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 (September 6, 1996)
  • K952201 — PORT-A-CATH ACCESS KIT (October 4, 1995)
  • K952416 — TRACHEOSTOMY CARE KIT (August 9, 1995)
  • K952256 — PICC LINE KIT (July 31, 1995)
  • K952007 — ADHEROL SEPP APPLICATOR (June 8, 1995)
  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K923516 — COMPOUND BENZOIN TINCTURE USP SEPP (January 25, 1994)
  • K920399 — COMPOUND BENZOIN TINCTURE USP FREPP (January 25, 1994)
  • K930196 — CEPTI-SEAL I.V. PREP KIT (July 2, 1993)

Other clearances for product code FMF

  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)

FDA data resources