Cleared Traditional

K844012 - OHMEDA ANESTHESIA RECORD KEEPER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844012 · Ohmeda Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
6d
Days
Class 2
Risk

K844012 is an FDA 510(k) clearance for the OHMEDA ANESTHESIA RECORD KEEPER. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 K844012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1984
Decision Date October 18, 1984
Days to Decision 6 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 139d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 186
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K844012.
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features)
K251352 · Codonics.Incorporated · Jul 2025
Carestation 750/750c
K213867 · Datex-Ohmeda, Inc. · Mar 2023
A8, A9 Anesthesia System
K201957 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2021