Cleared Traditional

BIO*NEPHROSS I.Q. ANDANTE (K882339) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882339 · Organon Teknika Corp. · Gastroenterology & Urology device
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Jun 1988
Decision
22d
Days
Class 2
Risk

K882339 is an FDA 510(k) clearance for the BIO*NEPHROSS I.Q. ANDANTE. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on June 28, 1988 after a review of 22 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

Submission Details

510(k) Number K882339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1988
Decision Date June 28, 1988
Days to Decision 22 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
108d faster than avg
Panel avg: 130d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 35
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K882339.
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680 · Baxter Healthcare Corp · Jul 1988
NEPHROSS I.Q. ALLEGO
K882213 · Organon Teknika Corp. · Jun 1988
NEPHROSS I.Q. MODERATO
K882215 · Organon Teknika Corp. · Jun 1988
NEPHROSS I.Q. ANDANTE
K874549 · Organon Teknika Corp. · Jan 1988
CAPILLARY FLOW DIALYZERS
K874728 · Baxter Healthcare Corp · Jan 1988
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471 · Travenol Laboratories, S.A. · Jun 1987