Cleared Traditional

K993582 - MODIFICATION TO LASER-SHIELD II

K993582 is an FDA 510(k) clearance for MODIFICATION TO LASER-SHIELD II, manufactured by Xomed, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993582 · Xomed, Inc. · Anesthesiology device
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Jan 2000
Decision
90d
Days
Class 2
Risk

K993582 is an FDA 510(k) clearance for the MODIFICATION TO LASER-SHIELD II. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Xomed, Inc. devices

FDA 510(k) Submission Details - K993582

510(k) Number K993582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1999
Decision Date January 20, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 185
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K993582.
RUSCH EDGAR TUBE
K021540 · Rusch Intl. · Aug 2002
ILM ENDOTRACHEAL TUBE
K991580 · The Laryngeal Mask Co., Ltd. · Feb 2000
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
K993786 · Rusch Intl. · Feb 2000
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
K990619 · Rusch Intl. · Aug 1999
PARKER FLEX-TIP TRACHEAL TUBE
K984528 · Parker Medical Assoc. · Jul 1999
ESOPHAGEAL INTUBATION DETECTOR
K990556 · Wolfe Tory Medical, Inc. · Mar 1999