Cleared Traditional

K855108 - RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR

K855108 is an FDA 510(k) clearance for RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR, manufactured by Biomaterials International, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K855108 · Biomaterials International, Inc. · Chemistry device
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Feb 1986
Decision
60d
Days
Class 1
Risk

K855108 is an FDA 510(k) clearance for the RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Biomaterials International, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 21, 1986 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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.

View all Biomaterials International, Inc. devices

FDA 510(k) Submission Details - K855108

510(k) Number K855108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date February 21, 1986
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 166
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K855108.
THE PARTNER SPECTROPHOTOMETER
K861617 · Pharmacia, Inc. · May 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · Pharmacia, Inc. · May 1986
ULTROSPEC K KINETICS SPECTROPHOTOMETER
K861194 · Lkb Instruments, Inc. · Apr 1986
TERUMO SENSIBEAD EIA COLORIMETER
K854210 · Terumo Medical Corp. · Dec 1985
RAICHEM/K.E
K854540 · Reagents Applications, Inc. · Nov 1985
MR 700 MICROPLATE READER 012-700-1000
K854303 · Dynatech Laboratories, Inc. · Nov 1985