Cleared Traditional

K891316 - ANESTHESIA/RESPIRATORY DISPOSABLE MASK

K891316 is an FDA 510(k) clearance for ANESTHESIA/RESPIRATORY DISPOSABLE MASK, manufactured by Concord/Portex. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K891316 · Concord/Portex · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
161d
Days
Class 1
Risk

K891316 is an FDA 510(k) clearance for the ANESTHESIA/RESPIRATORY DISPOSABLE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 161 days - an extended review cycle.

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.

View all Concord/Portex devices

FDA 510(k) Submission Details - K891316

510(k) Number K891316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1989
Decision Date August 21, 1989
Days to Decision 161 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
21d slower than avg
Panel avg: 140d · This submission: 161d
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 28
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K891316.
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
K951043 · Promedic, Inc. · Jun 1995
AMBU DISPOSABLE FACE MASK
K932014 · Ambu, Inc. · Jun 1993
VENTLAB VENT-MASK, CAT# VR 0010/20/30
K903881 · Ventlab Corp. · Sep 1990
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989
MODIFIED CUSHION-FLEX(TM)
K890108 · Life Design Systems, Inc. · Jan 1989
CUSHION FLEX(TM)
K884387 · Life Design Systems, Inc. · Nov 1988