Cleared Traditional

K810620 - DISPOSABLE ELBOW ADAPTOR

K810620 is the FDA 510(k) clearance for DISPOSABLE ELBOW ADAPTOR by Intec Medical, Inc.. It is a Class 1 Anesthesiology device (product code BZA) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K810620 · Intec Medical, Inc. · Anesthesiology device

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Mar 1981

Decision

11d

Days

Class 1

Risk

K810620 is an FDA 510(k) clearance for the DISPOSABLE ELBOW ADAPTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Intec Medical, Inc. (Blue Springs, US). The FDA issued a Cleared decision on March 20, 1981 after a review of 11 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 Intec Medical, Inc. devices

Submission Details

510(k) Number	K810620 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 09, 1981
Decision Date	March 20, 1981
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

129d faster than avg

Panel avg: 140d · This submission: 11d

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 18

Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K810620.

PEDIATRIC DOUBLE SWIVEL CONNECTOR

K812000 · Mallinckrodt Critical Care · Aug 1981

DISPOSABLE TRACH T OXYGENATOR

K811890 · Airlife, Inc. · Jul 1981

UNIVERSAL ADAPTER SYSTEM-U/ADAPIT

K811708 · Airlife, Inc. · Jul 1981

BLOW-BY-SET-UP CONNECTOR-AIRWAY

K802663 · Airlife, Inc. · Nov 1980

TRACH T WITH ONE-WAY VALVES

K790888 · Airlife, Inc. · Jun 1979

TEE ADAPTER

K790887 · Airlife, Inc. · Jun 1979

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 K810620

Intec Medical, Inc.

Blue Springs, MO · US

J.W. Brown

Regulatory profile

17 submissions 17 cleared

100% 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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