Cleared Traditional

K844748 - NEPHROSS ALLEGRO H.F.

K844748 is an FDA 510(k) clearance for NEPHROSS ALLEGRO H.F., manufactured by Organon Teknika Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K844748 · Organon Teknika Corp. · Gastroenterology & Urology device
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Jan 1985
Decision
47d
Days
Class 2
Risk

K844748 is an FDA 510(k) clearance for the NEPHROSS ALLEGRO H.F.. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Oklahoma City, US). The FDA issued a Cleared decision on January 22, 1985 after a review of 47 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K844748

510(k) Number K844748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1984
Decision Date January 22, 1985
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 130d · This submission: 47d
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 31
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K844748.
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K844756 · Travenol Laboratories, S.A. · Jan 1985
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K842154 · Organon Teknika Corp. · Jul 1984