Cleared Traditional

K823115 - NATURALYTE BICARBONATE DIALYSATE 4400

K823115 is an FDA 510(k) clearance for NATURALYTE BICARBONATE DIALYSATE 4400, manufactured by Erika, Inc.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K823115 · Erika, Inc. · Orthopedic device
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Dec 1982
Decision
43d
Days
Class 2
Risk

K823115 is an FDA 510(k) clearance for the NATURALYTE BICARBONATE DIALYSATE 4400. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Erika, Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - the FDA orthopedic device regulatory 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 Erika, Inc. devices

FDA 510(k) Submission Details - K823115

510(k) Number K823115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1982
Decision Date December 03, 1982
Days to Decision 43 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
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: 122d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 71
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K823115.
DCW MODULAR DISTAL FEMORAL SYSTEM
K910596 · Dow Corning Wright · May 1991
S-ROM/NOILES MARK 3
K896048 · Joint Medical Products Corp. · Mar 1990
KINEMATIC II KNEE SYSTEM
K823420 · Howmedica Corp. · Feb 1983
BARD ENDO LINK INTRACONDYLAR ROTATING
K821476 · C.R. Bard, Inc. · Jun 1982
VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
K821340 · Intermedics Orthopedics · May 1982
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
K810520 · Zimmer, Inc. · Mar 1981