Cleared Traditional

K900185 - NIIC MODEL: DX901 ASPIRATION SYSTEM

K900185 is an FDA 510(k) clearance for NIIC MODEL: DX901 ASPIRATION SYSTEM, manufactured by Niic U.S.A., Inc.. The device is a Class 2 Chemistry device with product code JFL cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K900185 · Niic U.S.A., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
128d
Days
Class 2
Risk

K900185 is an FDA 510(k) clearance for the NIIC MODEL: DX901 ASPIRATION SYSTEM. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Niic U.S.A., Inc. (Redwood City, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Niic U.S.A., Inc. devices

FDA 510(k) Submission Details - K900185

510(k) Number K900185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date May 24, 1990
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFL Device Classification - Class 2, Special Controls

Product Code JFL Ph Rate Measurement, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 Chemistry devices follow this clearance model.

Regulatory Peers - JFL Ph Rate Measurement, Carbon-dioxide

All 23
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K900185.
SIGMA ELECTROLYTE BUFFER
K933695 · Sigma Chemical Co. · Oct 1993
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552 · Hichem Diagnostics · Feb 1993
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
K925553 · Hichem Diagnostics · Feb 1993
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183 · Beckman Instruments, Inc. · Mar 1990
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420 · American Research Products Co. · Mar 1990
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · Shaban Mfg. Co. · Aug 1984