Cleared Traditional

K862688 - OHMEDA 5420 VOLUME MONITOR

K862688 is an FDA 510(k) clearance for OHMEDA 5420 VOLUME MONITOR, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K862688

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.

BZK Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K862688.
BEAR NVM-1
K872660 · Bear Medical Systems, Inc. · Feb 1988
RESPIRADYNE II(TM)
K863866 · Chesebrough-Pond'S U.S.A. Co. · Jan 1987
OHMEDA 5410 VOLUME MONITOR
K862687 · Ohmeda Medical · Sep 1986
BEAR NICU-1
K853346 · Bear Medical Systems, Inc. · Sep 1985
OHMEDA RM311 RESPIROMETER
K843799 · Ohmeda Medical · Oct 1984
OHMEDA RM121 RESPIROMETER
K843800 · Ohmeda Medical · Oct 1984