Cleared Traditional

ASN MONITOR SINGLE NEEDLE MONITOR (K843531) - FDA 510(k) Clearance

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

K843531 · Organon Teknika Corp. · Gastroenterology & Urology device
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Nov 1984
Decision
70d
Days
Class 2
Risk

K843531 is an FDA 510(k) clearance for the ASN MONITOR SINGLE NEEDLE MONITOR. 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 November 16, 1984 after a review of 70 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K843531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date November 16, 1984
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
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 K843531.
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
FAST FORMALERT
K853555 · Organon Teknika Corp. · Jun 1986
HOLLOW FIBER DIALYZER
K843632 · Travenol Laboratories, S.A. · Oct 1984
CAPILLARY FLOW DIALYZERS
K840937 · Travenol Laboratories, S.A. · Sep 1984
HOLLOW FIBER DIALYZERS
K840845 · Travenol Laboratories, S.A. · Aug 1984