Cleared Traditional

K933511 - UPGRADED SPIROMETER ST-90

K933511 is an FDA 510(k) clearance for UPGRADED SPIROMETER ST-90, manufactured by Futuremed Div. of Future Impex Corp.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K933511 · Futuremed Div. of Future Impex Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
210d
Days
Class 2
Risk

K933511 is an FDA 510(k) clearance for the UPGRADED SPIROMETER ST-90. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Futuremed Div. of Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 210 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 Futuremed Div. of Future Impex Corp. devices

FDA 510(k) Submission Details - K933511

510(k) Number K933511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1993
Decision Date February 10, 1994
Days to Decision 210 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
70d slower than avg
Panel avg: 140d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K933511.
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K942211 · Sensor Medics Corp. · Nov 1994
FLOWSCREEN
K932744 · Erich Jaeger, Inc. · Mar 1994
MASTER SCREEN PNUEMO
K933839 · Erich Jaeger, Inc. · Mar 1994
MODEL 508 PATIENT MONITOR
K921309 · Criticare Systems, Inc. · Dec 1993
VITALOGRAPH DATA STORAGE SPIROMETER
K930085 · Vitalograph , Ltd. · Jul 1993
L.A.P. SPIROMETER
K864836 · Timeter Instrument Corp. · Mar 1987