Cleared Traditional

K855070 - SPIROMETER MODEL TS-200 SLZ 7541

K855070 is the FDA 510(k) clearance for SPIROMETER MODEL TS-200 SLZ 7541 by Teledyne Avionics Div. of Teledyne. It is a Class 2 Anesthesiology device (product code BZC) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K855070 · Teledyne Avionics Div. of Teledyne · Anesthesiology device
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Jan 1986
Decision
43d
Days
Class 2
Risk

K855070 is an FDA 510(k) clearance for the SPIROMETER MODEL TS-200 SLZ 7541. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Teledyne Avionics Div. of Teledyne (Charlottesville, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teledyne Avionics Div. of Teledyne devices

Submission Details

510(k) Number K855070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1985
Decision Date January 30, 1986
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 8
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