Cleared Traditional

K864285 - TERUMO OVATION SPECTROPHOTOMETER

K864285 is an FDA 510(k) clearance for TERUMO OVATION SPECTROPHOTOMETER, manufactured by Terumo Medical Corp.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K864285 · Terumo Medical Corp. · Chemistry device
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Jan 1987
Decision
71d
Days
Class 1
Risk

K864285 is an FDA 510(k) clearance for the TERUMO OVATION SPECTROPHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on January 9, 1987 after a review of 71 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K864285

510(k) Number K864285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1986
Decision Date January 09, 1987
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 147
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K864285.
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)
K871415 · Dynatech Laboratories, Inc. · Apr 1987
ADX(TM) ANALYZER
K864566 · Abbott Laboratories · Feb 1987
OHMEDA 6000 MULTI-GAS MONITOR
K863959 · Ohmeda Medical · Jan 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986
BEHRING RAPIMAT II
K861263 · Behring Diagnostics, Inc. · Oct 1986
UNISKAN II
K861897 · Flow Laboratories, Inc. · Jul 1986