Cleared Traditional

K133722 - ASTHMA MONITOR AM3

K133722 is an FDA 510(k) clearance for ASTHMA MONITOR AM3, manufactured by Eresearch Technology. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K133722 · Eresearch Technology · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
154d
Days
Class 2
Risk

K133722 is an FDA 510(k) clearance for the ASTHMA MONITOR AM3. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Eresearch Technology (Philadelphia, US). The FDA issued a Cleared decision on May 8, 2014 after a review of 154 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 Eresearch Technology devices

FDA 510(k) Submission Details - K133722

510(k) Number K133722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2013
Decision Date May 08, 2014
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 122
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K133722.
NeumoFilt Ergo/Neumo Filt BiteOn
K142303 · Medical Respiratory Devices S.L. · Nov 2014
VITALOGRAPH MODEL 7000 SPIROTRAC
K141546 · Vitalograph (Ireland) , Ltd. · Sep 2014
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
K133428 · Medikro OY · May 2014
SPM-300
K130322 · Bionet Co., Ltd. · Nov 2013
SPIROTEL
K130784 · Mir Medical Intl. Research Srl · Oct 2013
CCS-200 SPIROMETER
K123896 · Benson Medical Instruments Co. · Sep 2013