Cleared Traditional

K980658 - PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234

K980658 is an FDA 510(k) clearance for PSN DIALYZER, 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 89-day FDA review.

K980658 · Baxter Healthcare Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
89d
Days
Class 2
Risk

K980658 is an FDA 510(k) clearance for the PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on May 19, 1998 after a review of 89 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 - K980658

510(k) Number K980658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1998
Decision Date May 19, 1998
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 131d · This submission: 89d
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 K980658.
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
K990159 · Dynamic Technology Corp. · Apr 1999
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
K982337 · Haidylena Medical Egypt · Dec 1998
ULTRACON ULTRAFILTRATOR
K981253 · Interpore Intl. · Dec 1998
ULTRACON ULTRAFILTRATOR
K971710 · Quantic Biomedical, Inc. · Feb 1998
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · Terumo Medical Corp. · Dec 1997
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
K973291 · Dynamic Technology Corp. · Dec 1997