Cleared Traditional

K810620 - DISPOSABLE ELBOW ADAPTOR

K810620 is an FDA 510(k) clearance for DISPOSABLE ELBOW ADAPTOR, manufactured by Intec Medical, Inc.. The device is a Class 1 Anesthesiology device with 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

FDA 510(k) Submission Details - K810620

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 140d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

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 57
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K810620.
DISPOSABLE TRACH T OXYGENATOR
K811890 · Airlife, Inc. · Jul 1981
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT
K811708 · Airlife, Inc. · Jul 1981
DISPOSABLE 22MM. FLEXIBLE ADAPTOR
K810621 · Intec Medical, Inc. · Apr 1981
BLOW-BY-SET-UP CONNECTOR-AIRWAY
K802663 · Airlife, Inc. · Nov 1980
DISPOSABLE AEROSOL T
K791538 · Hospitak, Inc. · Sep 1979
DISPOSABLE 22MM ADAPTOR
K791539 · Hospitak, Inc. · Sep 1979