Cleared Traditional

K042595 - SPIRO'AIR

K042595 is an FDA 510(k) clearance for SPIRO'AIR, manufactured by Morgan Scientific, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K042595 · Morgan Scientific, Inc. · Anesthesiology device
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May 2005
Decision
223d
Days
Class 2
Risk

K042595 is an FDA 510(k) clearance for the SPIRO'AIR. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Morgan Scientific, Inc. (Haverhill, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 223 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Morgan Scientific, Inc. devices

FDA 510(k) Submission Details - K042595

510(k) Number K042595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2004
Decision Date May 04, 2005
Days to Decision 223 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
83d slower than avg
Panel avg: 140d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 152
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K042595.
POLYTECH PULMONARY FUNCTION FILTER
K042758 · Polytechnic Resources, Inc. · Aug 2005
SPIROTEL
K043528 · Mir Medical Intl. Research Srl · Jul 2005
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
K050424 · Fim Medical · Jun 2005
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
K042058 · Clement Clarke Intl., Ltd. · Mar 2005
SPIROTEL, MODEL 29-1020
K031643 · Sdi Diagnostics, Inc. · Dec 2003
MICROLAB SPIROMETER
K031102 · Micro Direct, Inc. · Dec 2003