Cleared Traditional

K981744 - COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER

K981744 is an FDA 510(k) clearance for COMBINATION TOA WITH NASAL MASK HOLDER ..., manufactured by W. Keith Thornton, D.D.S.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K981744 · W. Keith Thornton, D.D.S. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
149d
Days
Class 2
Risk

K981744 is an FDA 510(k) clearance for the COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by W. Keith Thornton, D.D.S. (Dallas, US). The FDA issued a Cleared decision on October 14, 1998 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 W. Keith Thornton, D.D.S. devices

FDA 510(k) Submission Details - K981744

510(k) Number K981744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date October 14, 1998
Days to Decision 149 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
9d slower than avg
Panel avg: 140d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 336
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K981744.
INVACARE CPAP
K982242 · Invacare Corp. · Jan 1999
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K980551 · Nidek Medical Products, Inc. · Nov 1998
SULLIVAN MIRAGE FULL FACE MASK
K982530 · Resmed, Ltd. · Oct 1998
SULLIVAN AUTOSET
K980721 · Resmed, Ltd. · Sep 1998
NASAL INTERFACE MODEL 7910
K974453 · Healthdyne Technologies, Inc. · Aug 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365 · Nellcor Puritan Bennett, Inc. · Jul 1998