Cleared Traditional

K992594 - A-15 HEMODIALYZER

K992594 is an FDA 510(k) clearance for A-15 HEMODIALYZER, manufactured by Althin Medical AB. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K992594 · Althin Medical AB · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
52d
Days
Class 2
Risk

K992594 is an FDA 510(k) clearance for the A-15 HEMODIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Althin Medical AB (Ronneby, SE). The FDA issued a Cleared decision on September 24, 1999 after a review of 52 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 Althin Medical AB devices

FDA 510(k) Submission Details - K992594

510(k) Number K992594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1999
Decision Date September 24, 1999
Days to Decision 52 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
79d faster than avg
Panel avg: 131d · This submission: 52d
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 K992594.
ULTRACONCENTRATOR SYSTEM
K011148 · Interpore Cross Intl. · Jun 2001
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
K002761 · Fresenius Medical Care North America · Dec 2000
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908 · Idemsa · Apr 2000
A-18 HEMODIALYZER
K992565 · Althin Medical AB · Sep 1999
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
K991512 · Asahi Medical Co., Ltd. · Jul 1999
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
K990159 · Dynamic Technology Corp. · Apr 1999