Cleared Traditional

K890606 - OHMEDA 5330 AGENT MONITOR

K890606 is the FDA 510(k) clearance for OHMEDA 5330 AGENT MONITOR by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code CBQ) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K890606 · Ohmeda Medical · Anesthesiology device

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Apr 1989

Decision

73d

Days

Class 2

Risk

K890606 is an FDA 510(k) clearance for the OHMEDA 5330 AGENT MONITOR. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Ohmeda Medical (Englewood, US). The FDA issued a Cleared decision on April 20, 1989 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - the FDA anesthesiology and respiratory 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 Ohmeda Medical devices

Submission Details

510(k) Number	K890606 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 06, 1989
Decision Date	April 20, 1989
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

67d faster than avg

Panel avg: 140d · This submission: 73d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.1500

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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

All 13

Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K890606.

NGM FRAME

K911644 · Datex Division Instrumentarium Corp. · Mar 1992

NGM GAS MODULE

K911647 · Datex Division Instrumentarium Corp. · Sep 1991

CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR

K903104 · Datex Division Instrumentarium Corp. · Jan 1991

PB GRAPHICS PRINTER AND PB VIDEO DISPLAY

K863248 · Datex Division Instrumentarium Corp. · Sep 1986

OHMEDA 5300 ANESTHETIC AGENT MONITOR

K861397 · Ohmeda Medical · May 1986

PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT

K861474 · Datex Division Instrumentarium Corp. · May 1986

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K890606

Ohmeda Medical

Englewood, CO · US

AMRIK SIKAND

Regulatory profile

120 submissions 118 cleared

98% clearance rate · Active in Anesthesiology

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Sourced from FDA 510(k) public files . Updated monthly.

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