Cleared Traditional

K860296 - HEMODIALYSIS CONCENTRATE FORMULATIONS/A...

K860296 is an FDA 510(k) clearance for HEMODIALYSIS CONCENTRATE FORMULATIONS/A..., manufactured by Physicians Surgeons Purchasing Group. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K860296 · Physicians Surgeons Purchasing Group · Gastroenterology & Urology device
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Mar 1986
Decision
35d
Days
Class 2
Risk

K860296 is an FDA 510(k) clearance for the HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Physicians Surgeons Purchasing Group (Los Angeles, US). The FDA issued a Cleared decision on March 4, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Physicians Surgeons Purchasing Group devices

FDA 510(k) Submission Details - K860296

510(k) Number K860296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1986
Decision Date March 04, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKQ Device Classification - Class 2, Special Controls

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKQ System, Dialysate Delivery, Central Multiple Patient

All 32
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K860296.
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