Cleared Traditional

K864836 - L.A.P. SPIROMETER

K864836 is an FDA 510(k) clearance for L.A.P. SPIROMETER, manufactured by Timeter Instrument Corp.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K864836 · Timeter Instrument Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
87d
Days
Class 2
Risk

K864836 is an FDA 510(k) clearance for the L.A.P. SPIROMETER. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Timeter Instrument Corp. (Lancaster, US). The FDA issued a Cleared decision on March 6, 1987 after a review of 87 days - a notably fast clearance 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: 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 Timeter Instrument Corp. devices

FDA 510(k) Submission Details - K864836

510(k) Number K864836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date March 06, 1987
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 K864836.
UPGRADED SPIROMETER ST-90
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K921309 · Criticare Systems, Inc. · Dec 1993
VITALOGRAPH DATA STORAGE SPIROMETER
K930085 · Vitalograph , Ltd. · Jul 1993
SPIROMETRY MODULE
K861486 · Medical Graphics Corp. · May 1986
VITALOGRAPH PFT PRINTER
K823683 · Vitalograph , Ltd. · Jan 1983
PFT SCREENER (SYSTEM 1100)
K812792 · Medical Graphics Corp. · Nov 1981