Cleared Traditional

K991412 - VITALOGRAPH MICRO

K991412 is an FDA 510(k) clearance for VITALOGRAPH MICRO, manufactured by Vitalograph, Inc.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K991412 · Vitalograph, Inc. · Anesthesiology device
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Feb 2000
Decision
287d
Days
Class 2
Risk

K991412 is an FDA 510(k) clearance for the VITALOGRAPH MICRO. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Vitalograph, Inc. (Lenexa, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 287 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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 Vitalograph, Inc. devices

FDA 510(k) Submission Details - K991412

510(k) Number K991412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date February 04, 2000
Days to Decision 287 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
147d slower than avg
Panel avg: 140d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZH Device Classification - Class 2, Special Controls

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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 - BZH Meter, Peak Flow, Spirometry

All 50
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K991412.
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · Monaghan Medical Corp. · May 2003
TRUEZONE PEAK FLOW METER
K023097 · Monaghan Medical Corp. · Mar 2003
ONEFLOW
K980951 · Sti Medical · Feb 2000
RESPALERT
K992618 · Harwill Medical (Pty) , Ltd. · Oct 1999
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · Monaghan Medical Corp. · Jul 1999
AIRZONE PEAK FLOWMETER
K982334 · Clement Clarke Intl., Ltd. · Jan 1999