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510(k) K222385

Bifurcated Needle by Anhui Tiankang Medical Technology Co., Ltd. — Product Code SCL

K222385 is an FDA 510(k) premarket notification submitted by Anhui Tiankang Medical Technology Co., Ltd. for the device "Bifurcated Needle". The FDA issued a decision of Substantially Equivalent on December 6, 2022. The device falls under product code SCL (Allergen And Vaccine Delivery Needles), a Class II device regulated under 21 CFR 880.5570. Anhui Tiankang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2022
Date Received
August 8, 2022
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 Anhui Tiankang Medical Technology Co., Ltd.

  • K222772 — Oral/Enteral Syringe with ENFit connector (August 17, 2023)
  • K222773 — Feeding Tube (August 17, 2023)
  • K230756 — TK Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K220204 — Disposabel Syringe with permanently attached needle, Safety Syringe with permane (July 14, 2022)
  • K212368 — Surgical Face Mask (October 24, 2021)
  • K210464 — Auto Disable Syringe (August 24, 2021)
  • K191639 — TK Insulin Syringe with/without Saftey Retractable Device (September 11, 2020)
  • K191640 — TK Intravascular Administration Set (August 26, 2020)
  • K191644 — TK Safety Needle (August 6, 2020)
  • K191642 — TK Sterile Piston Syringe without Needle (January 6, 2020)

Other clearances for product code SCL

  • K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS (January 30, 2026)
  • 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)
  • K020523 — BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 (March 20, 2002)
  • 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