Home / 510(k) Clearances / K023092

510(k) K023092

BD K-4000 MICROKERATOME SYSTEM by Becton, Dickinson & CO — Product Code HMY

K023092 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD K-4000 MICROKERATOME SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 2002. The device falls under product code HMY (Keratome, Battery-Powered), a Class I device regulated under 21 CFR 886.4370. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2002
Date Received
September 18, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Battery-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Becton, Dickinson & CO

  • K260128 — BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (April 15, 2026)
  • K252378 — BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillar (April 10, 2026)
  • K252506 — BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Bloo (April 10, 2026)
  • K260184 — Onclarity™ Self-Collection Kit (April 2, 2026)
  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus fo (October 31, 2025)
  • K250059 — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (September 12, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)

Other clearances for product code HMY

  • K040297 — ONEUSE- PLUS MICROKERATOME (March 31, 2004)
  • K022637 — BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (October 16, 2002)
  • K022560 — M2 SINGLE USE MICROKERTOME (September 27, 2002)
  • K003594 — CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (March 9, 2001)
  • K002191 — CARRIAZO BARRAQUER II MICROKERATOME (October 12, 2000)
  • K992687 — MILLENIUM MICROKERATOME, MODEL IMD-001 (September 24, 1999)
  • K984537 — KERATOME SYSTEM, MODEL K3000 (May 14, 1999)
  • K981741 — CARRIAZO BARRAQUER MICROKERATOME (July 24, 1998)
  • K974243 — KERATOME SYSTEM (January 20, 1998)
  • K902857 — VISI-DRAPE OPHTHALMIC DRAPES (July 31, 1990)

FDA data resources