Cleared Traditional

K873562 - VITALOGRAPH-ALPHA

K873562 is an FDA 510(k) clearance for VITALOGRAPH-ALPHA, manufactured by Vitalograph , Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K873562 · Vitalograph , Ltd. · Anesthesiology device
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Aug 1988
Decision
362d
Days
Class 2
Risk

K873562 is an FDA 510(k) clearance for the VITALOGRAPH-ALPHA. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on August 29, 1988 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Vitalograph , Ltd. devices

FDA 510(k) Submission Details - K873562

510(k) Number K873562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1987
Decision Date August 29, 1988
Days to Decision 362 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
222d slower than avg
Panel avg: 140d · This submission: 362d
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 65
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K873562.
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
629V SPIROMETER, PULMONARY FUNCTION ANALYZER
K881402 · American Electromedics Corp. · Sep 1988
SPIRO ANALYZER ST-300
K873817 · Futuremed Div. of Future Impex Corp. · Dec 1987
SALTER VOLUCHEK 6600
K863656 · Salter Labs · Oct 1986
SCREENMATE
K853409 · Erich Jaeger, Inc. · Feb 1986