Cleared Traditional

K801261 - DISPOSABLE COUPLING ADAPTOR

K801261 is an FDA 510(k) clearance for DISPOSABLE COUPLING ADAPTOR, manufactured by Intec Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BYX cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K801261 · Intec Medical, Inc. · Anesthesiology device
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Jun 1980
Decision
12d
Days
Class 1
Risk

K801261 is an FDA 510(k) clearance for the DISPOSABLE COUPLING ADAPTOR. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Intec Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5860 - 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 - K801261

510(k) Number K801261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date June 09, 1980
Days to Decision 12 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
128d faster than avg
Panel avg: 140d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

BYX Device Classification - Class 1, General Controls

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
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 - BYX Tubing, Pressure And Accessories

All 24
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K801261.
TIMETER PRODUCED CHEMETRON (NCG) AIR
K811550 · Timeter Instrument Corp. · Jun 1981
TIMETER PRODUCED OHIO OXYGEN ADAPTOR
K811551 · Timeter Instrument Corp. · Jun 1981
TIMETER PRODUCED PURRITAN BENNETT O2 ADP
K801514 · Timeter Instrument Corp. · Jul 1980
DISPOSABLE PRESSURE LINE ADAPTOR
K801260 · Intec Medical, Inc. · Jun 1980
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP
K801190 · Airlife, Inc. · May 1980
SURE FLOW TUBING
K800664 · B & F Medical Products, Inc. · Apr 1980