Cleared Traditional

K944988 - CUSTOM MEDICAL SUSPENSION STRAP

K944988 is an FDA 510(k) clearance for CUSTOM MEDICAL SUSPENSION STRAP, manufactured by Custom Medical Specialties, Inc.. The device is a Class 1 Anesthesiology device with product code JAY cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K944988 · Custom Medical Specialties, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K944988

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
33d faster than avg
Panel avg: 140d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

JAY Device Classification - Class 1, General Controls

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.

Regulatory Peers - JAY Support, Breathing Tube

All 8
Devices cleared under the same product code (JAY) and FDA review panel - the closest regulatory comparables to K944988.
BLOCK, BITE, INTUBATION
K873491 · B&B Medical Technologies, Inc. · Oct 1987
COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
K850309 · Ackrad Laboratories · Feb 1985
COMFIT
K834089 · Ackrad Laboratories · Dec 1983
ENDOTRACHEAL TUBE HOLDER
K802675 · Respiratory Support Products, Inc. · Nov 1980
ADJUSTABLE TUBE TREE FOR ANESTH. HOSES
K792148 · Medical Innovations Corp. · Nov 1979
TUBE-STRAP
K791781 · Olympic Medical Corp. · Sep 1979