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510(k) K020523

BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 by Bd — Product Code SCL

K020523 is an FDA 510(k) premarket notification submitted by Bd for the device "BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757". The FDA issued a decision of Substantially Equivalent on March 20, 2002. The device falls under product code SCL (Allergen And Vaccine Delivery Needles), a Class II device regulated under 21 CFR 880.5570. Bd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2002
Date Received
February 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Allergen And Vaccine Delivery Needles
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.

Other clearances by Bd

  • K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (February 20, 2026)
  • K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (February 29, 2024)
  • K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
  • K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
  • K221504 — BD Surgiphor™ Antimicrobial Irrigation System (October 14, 2022)
  • K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (March 20, 2018)
  • K024240 — BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS (March 26, 2003)
  • K023752 — BD INTEGRA SYRINGE (February 7, 2003)
  • K021475 — BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET (July 19, 2002)
  • K011967 — BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE (January 23, 2002)

Other clearances for product code SCL

  • K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS (January 30, 2026)
  • K222385 — Bifurcated Needle (December 6, 2022)
  • K182582 — Oryum and Ovem Epidermal Deri Prick Test Applicator (April 10, 2019)
  • K172062 — AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Tes (March 5, 2018)
  • K162917 — Allerhope Allergy Skin Tester (August 17, 2017)
  • K032528 — BD ECLIPSE BIFURCATED NEEDLE (September 9, 2003)
  • K031630 — BIFURCATED ALLERGY SKIN TESTING NEEDLE (August 7, 2003)
  • K020500 — UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (March 19, 2002)
  • K012515 — BIFURCATED VACCINATING NEEDLE (September 19, 2001)
  • K011979 — ALLERSHARP ALLERGY SKIN TESTER (September 14, 2001)

FDA data resources