Cleared Traditional

K930085 - VITALOGRAPH DATA STORAGE SPIROMETER

K930085 is the FDA 510(k) clearance for VITALOGRAPH DATA STORAGE SPIROMETER by Vitalograph , Ltd.. It is a Class 2 Anesthesiology device (product code BTY) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K930085 · Vitalograph , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
200d
Days
Class 2
Risk

K930085 is an FDA 510(k) clearance for the VITALOGRAPH DATA STORAGE SPIROMETER. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on July 26, 1993 after a review of 200 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 , Ltd. devices

Submission Details

510(k) Number K930085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1993
Decision Date July 26, 1993
Days to Decision 200 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 140d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 10
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K930085.
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
K190800 · Cosmed Srl · Feb 2020
Ascent Cardiorespiratory Diagnostic Software
K181912 · Medical Graphics Corporation · Apr 2019
SpiroSphere
K173937 · Eresearchtechnology GmbH · Feb 2019
ELECTRONIC SPIROMETER MODEL MFR-8100
K810712 · Nihon Kohden America, Inc. · Mar 1981