Cleared Traditional

FAST FORMALERT (K853555) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853555 · Organon Teknika Corp. · Gastroenterology & Urology device
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Jun 1986
Decision
304d
Days
Class 2
Risk

K853555 is an FDA 510(k) clearance for the FAST FORMALERT. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Oklahoma City, US). The FDA issued a Cleared decision on June 26, 1986 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon Teknika Corp. devices

Submission Details

510(k) Number K853555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date June 26, 1986
Days to Decision 304 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
174d slower than avg
Panel avg: 130d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 36
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K853555.
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · Baxter Healthcare Corp · Oct 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106 · Baxter Healthcare Corp · May 1991
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · Baxter Healthcare Corp · Dec 1989
ASN MONITOR SINGLE NEEDLE MONITOR
K843531 · Organon Teknika Corp. · Nov 1984
HOLLOW FIBER DIALYZER
K843632 · Travenol Laboratories, S.A. · Oct 1984
CAPILLARY FLOW DIALYZERS
K840937 · Travenol Laboratories, S.A. · Sep 1984