Cleared Traditional

K843800 - OHMEDA RM121 RESPIROMETER

K843800 is the FDA 510(k) clearance for OHMEDA RM121 RESPIROMETER by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BZK) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K843800 · Ohmeda Medical · Anesthesiology device
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Oct 1984
Decision
7d
Days
Class 2
Risk

K843800 is an FDA 510(k) clearance for the OHMEDA RM121 RESPIROMETER. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Ohmeda Medical (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 7 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 K843800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date October 04, 1984
Days to Decision 7 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
133d faster than avg
Panel avg: 140d · This submission: 7d
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 K843800.
OHMEDA 5410 VOLUME MONITOR
K862687 · Ohmeda Medical · Sep 1986
OHMEDA 5420 VOLUME MONITOR
K862688 · Ohmeda Medical · Sep 1986
OHMEDA RM311 RESPIROMETER
K843799 · Ohmeda Medical · Oct 1984
MEDISHIELD PVM RESPIROMETER
K840453 · Ohio Medical Products · Mar 1984
PORTABLE MONITORING & SCREENING SPIROM.
K822689 · Boehringer Laboratories · Jul 1983
SPIROMED RESPIROMETER
K831237 · Draeger Medical, Inc. · May 1983