Cleared Traditional

K782145 - SPIROMETER, MINI POSITIVE

K782145 is an FDA 510(k) clearance for SPIROMETER, manufactured by Boehringer Laboratories. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K782145 · Boehringer Laboratories · Anesthesiology device
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Jan 1979
Decision
35d
Days
Class 2
Risk

K782145 is an FDA 510(k) clearance for the SPIROMETER, MINI POSITIVE. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Boehringer Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 31, 1979 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 Boehringer Laboratories devices

FDA 510(k) Submission Details - K782145

510(k) Number K782145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date January 31, 1979
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 28
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K782145.
COMPUTERIZED SPIROMETRY SYSTEM
K823922 · Ohio Medical Products · Feb 1983
BEAR VM-90 VENTILATION MONITOR
K822912 · Bear Medical Systems, Inc. · Nov 1982
RMS 111F RESPIRATORY MONITORING SYSTEM
K800086 · The Perkin-Elmer Corp. · May 1980
SPIROMETER, MONITORING W/ALARM
K780064 · Ohio Medical Products · Jan 1978
SPIROMETEO EXHAUST
K770907 · Timeter Instrument Corp. · Jul 1977
POSITIVE DISPLACEMENT SPIROMETER
K760971 · Boehringer Laboratories · Dec 1976