Cleared Traditional

K834538 - LAS-2 ALIGNMENT SYSTEM

K834538 is an FDA 510(k) clearance for LAS-2 ALIGNMENT SYSTEM, manufactured by Therados, Inc.. The device is a Class 2 Radiology device with product code KPO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K834538 · Therados, Inc. · Radiology device
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Feb 1984
Decision
71d
Days
Class 2
Risk

K834538 is an FDA 510(k) clearance for the LAS-2 ALIGNMENT SYSTEM. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Therados, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.5820 - the FDA radiology and imaging software oversight 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 Therados, Inc. devices

FDA 510(k) Submission Details - K834538

510(k) Number K834538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date February 21, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
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 Radiology devices follow this clearance model.

Regulatory Peers - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 86
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K834538.
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · Delmed, Inc. · Oct 1987
HOSPAL DIALYSATE FOR CAVHD
K861156 · Hospal Medical Corp. · Sep 1986
ULTRACLONE 05-100 GUINEA PIG RBC
K854206 · Earl-Clay Laboratories, Inc. · Oct 1985
CENTRALYTE BICARBONATE CONCENTRATE
K821304 · Erika, Inc. · May 1982
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · Erika, Inc. · Apr 1981
DIALYSATE CONCENTRATE FOR HEMODIALYSIS
K810280 · Cobe Laboratories, Inc. · Feb 1981