Cleared Traditional

K980876 - ASTHMA MONITOR AM2

K980876 is an FDA 510(k) clearance for ASTHMA MONITOR AM2, manufactured by Erich Jaeger GmbH & Co. KG. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K980876 · Erich Jaeger GmbH & Co. KG · Anesthesiology device
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Aug 1998
Decision
161d
Days
Class 2
Risk

K980876 is an FDA 510(k) clearance for the ASTHMA MONITOR AM2. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Erich Jaeger GmbH & Co. KG (Hoechberg, DE). The FDA issued a Cleared decision on August 14, 1998 after a review of 161 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 Erich Jaeger GmbH & Co. KG devices

FDA 510(k) Submission Details - K980876

510(k) Number K980876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1998
Decision Date August 14, 1998
Days to Decision 161 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
21d slower than avg
Panel avg: 140d · This submission: 161d
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 76
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K980876.
CAIRD TECHNOLOGY SPIROMETER
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FLOWMATE II PLUS, MODEL #4000
K982956 · Spirometrics Medical Equipment Co. · Nov 1998
SPIROCARD
K973138 · Qrs Diagnostic, LLC · Oct 1998
SPIROBANK PORTABLE PC BASED SPIROMETER
K973456 · Futuremed America, Inc. · Jul 1998
SPIROMETER MODEL NPB-500
K980441 · Nellcor Puritan Bennett, Inc. · Apr 1998
MICRODL DIARYCARD SPIROMETER
K965042 · Micro Direct, Inc. · Jun 1997