Cleared Traditional

K844656 - OHMEDA DOUBLE SWIVEL ADAPTER

K844656 is the FDA 510(k) clearance for OHMEDA DOUBLE SWIVEL ADAPTER by Ohmeda Medical. It is a Class 1 Anesthesiology device (product code BZA) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K844656 · Ohmeda Medical · Anesthesiology device

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Feb 1985

Decision

75d

Days

Class 1

Risk

K844656 is an FDA 510(k) clearance for the OHMEDA DOUBLE SWIVEL ADAPTER. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on February 12, 1985 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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	K844656 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 29, 1984
Decision Date	February 12, 1985
Days to Decision	75 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

65d faster than avg

Panel avg: 140d · This submission: 75d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	BZA Connector, Airway (extension)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 868.5810

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZA Connector, Airway (extension)

All 31

Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K844656.

CONNECTORS/VALVE INSERT

K860888 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986

DOUBLE-SWIVEL CONNECTOR

K850964 · Sheridan Catheter Corp. · May 1985

ARGYLE 15MM SWIVEL CONNECTOR

K850625 · Sherwood Medical Co. · Mar 1985

INSPIRATORY FORCE PRESSURE ADAPTOR

K812067 · Airlife, Inc. · Aug 1981

PEDIATRIC DOUBLE SWIVEL CONNECTOR

K812000 · Mallinckrodt Critical Care · Aug 1981

45DEGREES SWIVEL ELBOW

K811922 · Dhd Medical Products Div. Diemolding Corp. · Jul 1981

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 K844656

Ohmeda Medical

Madison, WI · US

RAYMOND T RIDDLE

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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