Cleared Traditional

K852310 - NATURALYTE BICARBONATE CONCENTRATE-DRY PACK

K852310 is an FDA 510(k) clearance for NATURALYTE BICARBONATE CONCENTRATE-DRY PACK, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K852310 · Erika, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
58d
Days
Class 2
Risk

K852310 is an FDA 510(k) clearance for the NATURALYTE BICARBONATE CONCENTRATE-DRY PACK. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Erika, Inc. (Rockleigh, US). The FDA issued a Cleared decision on July 26, 1985 after a review of 58 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 Erika, Inc. devices

FDA 510(k) Submission Details - K852310

510(k) Number K852310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date July 26, 1985
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKQ Device Classification - Class 2, Special Controls

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
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 - FKQ System, Dialysate Delivery, Central Multiple Patient

All 31
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K852310.
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
K861730 · Renal Systems, Inc. · Jun 1987
FOUR TANK DISSOLUTION MODULE
K864635 · National Medical Care, Medical Products Div., Inc. · Jan 1987
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445
K861472 · National Medical Care, Medical Products Div., Inc. · Jul 1986
NEPHROSS ALLEGRO H.F.
K844748 · Organon Teknika Corp. · Jan 1985
ST FAMILY OF HOLLOW FIBER DIALYZERS
K844756 · Travenol Laboratories, S.A. · Jan 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963 · Renal Systems, Inc. · Jan 1985