Cleared Traditional

K915558 - IAS ANESTHESIA MASK

K915558 is an FDA 510(k) clearance for IAS ANESTHESIA MASK, manufactured by Ias. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K915558 · Ias · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
119d
Days
Class 1
Risk

K915558 is an FDA 510(k) clearance for the IAS ANESTHESIA MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Ias (Newburgh, US). The FDA issued a Cleared decision on April 8, 1992 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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.

FDA 510(k) Submission Details - K915558

510(k) Number K915558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1991
Decision Date April 08, 1992
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

BSJ Device Classification - Class 1, General Controls

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
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 - BSJ Mask, Gas, Anesthetic

All 32
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K915558.
DISPOSABLE, PREFORMED FACE MASK
K944157 · Meridian Medical Systems, Inc. · Oct 1994
NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE
K932147 · Hans Rudolph, Inc. · Aug 1993
AMBU DISPOSABLE FACE MASK
K932014 · Ambu, Inc. · Jun 1993
VENTLAB VENT-MASK, CAT# VR 0010/20/30
K903881 · Ventlab Corp. · Sep 1990
ANESTHESIA/RESPIRATORY DISPOSABLE MASK
K891316 · Concord/Portex · Aug 1989
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989