Cleared Traditional

K881402 - 629V SPIROMETER

K881402 is an FDA 510(k) clearance for 629V SPIROMETER, manufactured by American Electromedics Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K881402 · American Electromedics Corp. · Anesthesiology device
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Sep 1988
Decision
175d
Days
Class 2
Risk

K881402 is an FDA 510(k) clearance for the 629V SPIROMETER, PULMONARY FUNCTION ANALYZER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by American Electromedics Corp. (Hudson, US). The FDA issued a Cleared decision on September 26, 1988 after a review of 175 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 American Electromedics Corp. devices

FDA 510(k) Submission Details - K881402

510(k) Number K881402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date September 26, 1988
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
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 44
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K881402.
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
SALTER VOLUCHEK 6600
K863656 · Salter Labs · Oct 1986
SCREENMATE
K853409 · Erich Jaeger, Inc. · Feb 1986
MODEL 2120 SPIROSCREEN
K854403 · Gould, Inc. · Jan 1986