Cleared Traditional

K884157 - MODIFIED TOUCH-ME-NOT MASK

K884157 is the FDA 510(k) clearance for MODIFIED TOUCH-ME-NOT MASK by Walt'S Products. It is a Class 1 Anesthesiology device (product code BSJ) cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K884157 · Walt'S Products · Anesthesiology device
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Aug 1989
Decision
321d
Days
Class 1
Risk

K884157 is an FDA 510(k) clearance for the MODIFIED TOUCH-ME-NOT MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Walt'S Products (Winston-Salem, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Walt'S Products devices

Submission Details

510(k) Number K884157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date August 21, 1989
Days to Decision 321 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 140d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K884157.
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989
NON CONDUCTIVE ANESTHESIA FACEMASK
K831713 · Vital Signs, Inc. · Jul 1983
NON CONDUCTIVE PEDIATRIC ANES. FACE
K821045 · Vital Signs, Inc. · Apr 1982
NON-CONDUCTIVE ANESTHESIA FACE MASK
K803185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1981
NON-CONDUCTIVE, SINGLE USE FACE MASK #55
K801251 · Vital Signs, Inc. · Jun 1980