Cleared Traditional

K862688 - OHMEDA 5420 VOLUME MONITOR

K862688 is the FDA 510(k) clearance for OHMEDA 5420 VOLUME MONITOR by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BZK) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K862688 · Ohmeda Medical · Anesthesiology device

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Sep 1986

Decision

59d

Days

Class 2

Risk

K862688 is an FDA 510(k) clearance for the OHMEDA 5420 VOLUME MONITOR. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Ohmeda Medical (Englewood, US). The FDA issued a Cleared decision on September 12, 1986 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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	K862688 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 15, 1986
Decision Date	September 12, 1986
Days to Decision	59 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

81d faster than avg

Panel avg: 140d · This submission: 59d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BZK Spirometer, Monitoring (w/wo Alarm)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.1850

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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 20

Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K862688.

CAPNOMAC ULTIMA ANESTHESIA MONITOR

K932098 · Datex Division Instrumentarium Corp. · Nov 1993

PARTNER VOLUME MONITOR

K901885 · Bird Products Corp. · Sep 1990

OHMEDA 5410 VOLUME MONITOR

K862687 · Ohmeda Medical · Sep 1986

OHMEDA RM311 RESPIROMETER

K843799 · Ohmeda Medical · Oct 1984

OHMEDA RM121 RESPIROMETER

K843800 · Ohmeda Medical · Oct 1984

MEDISHIELD PVM RESPIROMETER

K840453 · Ohio Medical Products · Mar 1984

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 K862688

Ohmeda Medical

Englewood, CO · US

WILLIAM W BELEW

Regulatory profile

120 submissions 118 cleared

98% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

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

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