Cleared Traditional

K951483 - CPR MICROMASK

K951483 is an FDA 510(k) clearance for CPR MICROMASK, manufactured by Plasco, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K951483 · Plasco, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
203d
Days
Class 2
Risk

K951483 is an FDA 510(k) clearance for the CPR MICROMASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Plasco, Inc. (Gurnee, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 203 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 - K951483

510(k) Number K951483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date October 19, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 140d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBP Valve, Non-rebreathing

All 90
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K951483.
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
K953349 · Spiracle Technology · Feb 1996
CPR SUPER POCKET PACK
K953230 · Formosa-Cj Health Business Corp. · Feb 1996
CPR MASK & RELATED FAMILY KITS
K953461 · Safetec of America, Inc. · Jan 1996
PERSHIELD CPR DEVICE
K940820 · Rabintex Industries, Ltd. · Sep 1995
3M FILTRETE(TM) AIR FILTER MEDIA
K946225 · Tagg Industries · May 1995
MOUTH-TO-MASK RESUSCITATOR
K940503 · Mtm Health Products , Ltd. · Mar 1995
K951483 · CPR MICROMASK
Download PDF Plasco, Inc.