Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff

Description

This guidance documentis intended to assist industry in preparing an Abbreviated premarket notification submission (510(k)) to establish that the device is substantially equivalent to a predicate hemodialysis blood tubing set for use as the extracorporeal blood circuit during hemodialysis treatment. This guidance document identifies specific recommendations for the content and format of an Abbreviated 510(k) submission for hemodialysis blood tubing sets. This version of the guidance is intended to clarify the April 14, 2008, guidance of the same title and is consistent with FDA’s original approach to premarket notification (510(k)) submissions.

Scope & Applicability

Regulatory Context

• 21CFR801.109§ 801.109 Prescription devices.

  A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

• 21CFR807.81§ 807.81 When a premarket notification submission is required.

  (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR807.92§ 807.92 Content and format of a 510(k) summary.

  (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →

• 21CFR876.5820§ 876.5820 Hemodialysis system and accessories.

  (a) Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and acceRead full regulation →

• CGMP/QSR/Medical Devices/Adulterated

  Envoy Medical Inc.

  2025-12-09

• CGMP/QSR/Medical Devices/Adulterated

  Hong Qiangxing Shenzhen Electronics Limited

  2025-11-25

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  SeniorLife Technologies, Inc.

  2025-09-16

• CGMP/QSR/Medical Devices/Adulterated

  Spectra Therapy, LLC

  2025-08-12

• CGMP/QSR/Medical Devices/Adulterated

  Mectronic Medicale S.R.L.

  2025-08-05

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

  WHOOP, Inc.

  2025-07-15

• CGMP/QSR/Medical Devices/Adulterated

  Aju Pharm Co., Ltd.

  2025-06-24

• CGMP/QSR/Medical Devices/Adulterated

  Sedecal S.A.

  2025-05-27

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  DRG Instruments GmbH

  2025-05-27

• CGMP/QSR/Medical Devices/Adulterated

  NeuroSync, Inc.

  2025-05-20

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