Cleared Traditional

K870889 - ACID FUCHSIN SOLUTIONS

K870889 is an FDA 510(k) clearance for ACID FUCHSIN SOLUTIONS, manufactured by D.R.G. Scientific Industries. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K870889 · D.R.G. Scientific Industries · Gastroenterology & Urology device
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Jul 1987
Decision
125d
Days
Class 2
Risk

K870889 is an FDA 510(k) clearance for the ACID FUCHSIN SOLUTIONS. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by D.R.G. Scientific Industries (East Boston, US). The FDA issued a Cleared decision on July 8, 1987 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all D.R.G. Scientific Industries devices

FDA 510(k) Submission Details - K870889

510(k) Number K870889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1987
Decision Date July 08, 1987
Days to Decision 125 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
6d faster than avg
Panel avg: 131d · This submission: 125d
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 36
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K870889.
TWO TANK DISSOLUTION MODULE
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MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
K874084 · National Medical Care, Medical Products Div., Inc. · Apr 1988
KAWASUMI A.V. FISTULA SET
K873421 · Kawasumi Laboratories Co., Ltd. · Oct 1987
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
K861730 · Renal Systems, Inc. · Jun 1987
FOUR TANK DISSOLUTION MODULE
K864635 · National Medical Care, Medical Products Div., Inc. · Jan 1987
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445
K861472 · National Medical Care, Medical Products Div., Inc. · Jul 1986