Cleared Traditional

K893420 - MASTERLAB PFT AND MASTERLAB BODY BOX

K893420 is an FDA 510(k) clearance for MASTERLAB PFT AND MASTERLAB BODY BOX, manufactured by Quinton, Inc.. The device is a Class 2 Anesthesiology device with product code CCM cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K893420 · Quinton, Inc. · Anesthesiology device
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Jun 1989
Decision
57d
Days
Class 2
Risk

K893420 is an FDA 510(k) clearance for the MASTERLAB PFT AND MASTERLAB BODY BOX. Classified as Plethysmograph, Pressure (product code CCM), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quinton, Inc. devices

FDA 510(k) Submission Details - K893420

510(k) Number K893420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1989
Decision Date June 23, 1989
Days to Decision 57 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
83d faster than avg
Panel avg: 140d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCM Device Classification - Class 2, Special Controls

Product Code CCM Plethysmograph, Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1750
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 - CCM Plethysmograph, Pressure

All 7
Devices cleared under the same product code (CCM) and FDA review panel - the closest regulatory comparables to K893420.
MASTERSCREEN PAED - BABY BODY
K081823 · Viasys Healthcare GmbH · May 2009
1085 ULTIMATE E PLETHYSMOGRAPH
K943259 · Medical Graphics Corp. · Apr 1995
INFANT BODY TEST
K853390 · Erich Jaeger, Inc. · Feb 1986
SYSTEM 1085 BODY PLETHYSMOGRAPH
K852088 · Medical Graphics Corp. · Jul 1985
UNIVERSAL-BODYTEST
K843846 · Erich Jaeger, Inc. · Feb 1985
BODYSCREEN II
K843851 · Erich Jaeger, Inc. · Feb 1985