Cleared Traditional

K882680 - ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA

K882680 is an FDA 510(k) clearance for ALTERNATE BLOOD PORT DESIGN FOR ADDIT. ..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K882680 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Jul 1988
Decision
23d
Days
Class 2
Risk

K882680 is an FDA 510(k) clearance for the ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on July 22, 1988 after a review of 23 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K882680

510(k) Number K882680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1988
Decision Date July 22, 1988
Days to Decision 23 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: 131d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

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 117
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K882680.
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
K883589 · Gambro, Inc. · Sep 1988
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
K881811 · Cobe Laboratories, Inc. · Sep 1988
MODIFIED TORAY FILTRYZER DIALYZERS
K882158 · Toray Industries (America), Inc. · Aug 1988
NEPHROSS I.Q. ALLEGO
K882213 · Organon Teknika Corp. · Jun 1988
NEPHROSS I.Q. MODERATO
K882215 · Organon Teknika Corp. · Jun 1988
BIO*NEPHROSS I.Q. ANDANTE
K882339 · Organon Teknika Corp. · Jun 1988