Cleared Traditional

K852285 - DADE BLOOD GAS AMPUL INJECTOR

K852285 is an FDA 510(k) clearance for DADE BLOOD GAS AMPUL INJECTOR, manufactured by American Dade. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K852285 · American Dade · Chemistry device
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Jul 1985
Decision
41d
Days
Class 1
Risk

K852285 is an FDA 510(k) clearance for the DADE BLOOD GAS AMPUL INJECTOR. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K852285

510(k) Number K852285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date July 09, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 89d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQW Station, Pipetting And Diluting, For Clinical Use

All 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K852285.
MODUMATIC (R) DILUTER
K861640 · Tri-Continent Scientific, Inc. · May 1986
POSID SAMPLER
K860508 · Organon Teknika Corp. · May 1986
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
K854406 · Tecan U.S., Ltd. · Feb 1986
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K851403 · Ventrex Laboratories, Inc. · Jun 1985
DROPSTIRS - PLASTIC DISPOSABLE PIPET
K850800 · Berwick Medical Products, Inc. · Apr 1985
EPPENDORF DILUTER
K844798 · Medical Technomics, Ltd. · Jan 1985
K852285 · DADE BLOOD GAS AMPUL INJECTOR
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