Cleared Traditional

K944988 - CUSTOM MEDICAL SUSPENSION STRAP (FDA 510(k) Clearance)

Class I Anesthesiology device.

K944988 · Custom Medical Specialties, Inc. · Anesthesiology device
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Jan 1995
Decision
107d
Days
Class 1
Risk

K944988 is an FDA 510(k) clearance for the CUSTOM MEDICAL SUSPENSION STRAP. Classified as Support, Breathing Tube (product code JAY), Class I - General Controls.

Submitted by Custom Medical Specialties, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5280 - 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 Custom Medical Specialties, Inc. devices

Submission Details

510(k) Number K944988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1994
Decision Date January 27, 1995
Days to Decision 107 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
32d faster than avg
Panel avg: 139d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAY Support, Breathing Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5280
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.