Cleared Traditional

K924997 - EDD

K924997 is an FDA 510(k) clearance for EDD, manufactured by Arc Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 907-day FDA review.

K924997 · Arc Medical, Inc. · Anesthesiology device
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Mar 1995
Decision
907d
Days
Class 2
Risk

K924997 is an FDA 510(k) clearance for the EDD. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Arc Medical, Inc. (Clarkston, US). The FDA issued a Cleared decision on March 28, 1995 after a review of 907 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Arc Medical, Inc. devices

FDA 510(k) Submission Details - K924997

510(k) Number K924997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date March 28, 1995
Days to Decision 907 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
767d slower than avg
Panel avg: 140d · This submission: 907d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 158
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K924997.
HEBELER SAFE-T-TUBE
K960450 · Boston Medical Products, Inc. · Apr 1996
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PRIMA GUEDEL AIRWAYS
K952013 · Prima, Inc. · May 1995
QUICK-LOCK
K945816 · B&B Medical Technologies, Inc. · Jan 1995
GENERAL ANESTHESIA SYSTEM
K945455 · Vital Signs, Inc. · Dec 1994
SURE-LOCK VENTILATOR TUBING HOLDER
K944324 · B&B Medical Technologies, Inc. · Nov 1994