Cleared Traditional

K903539 - SALTER LABS MODEL #1015

K903539 is an FDA 510(k) clearance for SALTER LABS MODEL #1015, manufactured by Salter Labs. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K903539 · Salter Labs · Anesthesiology device
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Dec 1990
Decision
132d
Days
Class 1
Risk

K903539 is an FDA 510(k) clearance for the SALTER LABS MODEL #1015. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 Salter Labs devices

FDA 510(k) Submission Details - K903539

510(k) Number K903539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date December 17, 1990
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 140d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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 - CBH Device, Fixation, Tracheal Tube

All 9
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K903539.
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · Applied Medical Technology, Inc. · Sep 2014
RESPIRONIC'S INFANT SECUREEASY
K882079 · Respironics, Inc. · Aug 1988
TRAKEFIT TRACHEOSTOMY TUBE HOLDER
K872277 · Ackrad Laboratories · Jul 1987
RESPIRONICS SECUREASY
K860845 · Respironics, Inc. · Mar 1986
OR TUBE RESTRAINT
K851874 · Kinetic Concepts, Inc. · Aug 1985
RESPIRONICS ENDO TUBE CONTROL SYS
K822794 · Respironics, Inc. · Oct 1982