Negative Pressure Arterial Blood

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833905 ↗

FDA Product Code

KOC

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Erika Hpf 100

  Class II

  FDA 510(k) K791320 Active Cleared 24 Sep 1979

• Micro-Coil 100 Coil Dialyzer

  Class II

  FDA 510(k) K800723 Active Cleared 14 May 1980

• Erika Hpf 300

  Class II

  FDA 510(k) K791322 Active Cleared 24 Sep 1979

• Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2

  Class II

  FDA 510(k) K850655 Active Cleared 7 Mar 1985

• National Med Care Infusion Pump Adm Set #95-0001-8

  Class II

  FDA 510(k) K853134 Active Cleared 6 Nov 1985

• Dialyzer, Magniflo 100 Parallel Plate

  Class II

  FDA 510(k) K781966 Active Cleared 21 Feb 1979

See all devices from Erika, Inc. →

• What is the Negative Pressure Arterial Blood used for?

  It is an accessory for blood circuits in hemodialysis, designed for use in medical procedures involving blood circulation, and is associated with the medical specialties of gastroenterology and urology as indicated in its FDA 510(k) submission.

• How is the Negative Pressure Arterial Blood supplied and what models are available?

  It is supplied by Erika, Inc. and is available in multiple models including K833905, K822796, K842436, K822225, and K792053, as listed in the device data.

• Is the Negative Pressure Arterial Blood sterile and intended for single-use or reuse?

  The device data does not specify sterility or single-use/reuse status; therefore, no information on these attributes can be provided based solely on the given facts.

• What regulatory pathway was used for the Negative Pressure Arterial Blood?

  The device received FDA 510(k) clearance through a traditional submission process, as indicated by the clearance_type field and the AUTHORIZATIONS field listing FDA_510K.