Cleared Traditional

K810374 - CORRUGATED FLEX TUBING #6000,

K810374 is an FDA 510(k) clearance for CORRUGATED FLEX TUBING #6000, manufactured by Todd Industries, Inc.. The device is a Class 1 Anesthesiology device with product code BYX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K810374 · Todd Industries, Inc. · Anesthesiology device
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Mar 1981
Decision
29d
Days
Class 1
Risk

K810374 is an FDA 510(k) clearance for the CORRUGATED FLEX TUBING #6000,. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Todd Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 29 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.

FDA 510(k) Submission Details - K810374

510(k) Number K810374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1981
Decision Date March 13, 1981
Days to Decision 29 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 140d · This submission: 29d
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 38
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K810374.
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR
K811549 · Timeter Instrument Corp. · Jun 1981
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 COUPLING ADAPTOR
K801261 · Intec Medical, Inc. · Jun 1980
DISPOSABLE PRESSURE LINE ADAPTOR
K801260 · Intec Medical, Inc. · Jun 1980
K810374 · CORRUGATED FLEX TUBING #6000,
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