Cleared Traditional

K802928 - SPIROMETRIC COMPUTER #SC-10

K802928 is an FDA 510(k) clearance for SPIROMETRIC COMPUTER #SC-10, manufactured by Cavitron Corp.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K802928 · Cavitron Corp. · Anesthesiology device
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Dec 1980
Decision
28d
Days
Class 2
Risk

K802928 is an FDA 510(k) clearance for the SPIROMETRIC COMPUTER #SC-10. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1980 after a review of 28 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 Cavitron Corp. devices

FDA 510(k) Submission Details - K802928

510(k) Number K802928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1980
Decision Date December 17, 1980
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K802928.
PULMONARY FUNCTION LAB SYSTEM 1070
K822986 · Medical Graphics Corp. · Nov 1982
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
K810751 · General Electric Co. · Apr 1981
INSPIRON PULMONARY FUNCTION ANALYZER
K802920 · C.R. Bard, Inc. · Feb 1981
INFANT VENTILATORY MEASUREMENT SYSTEM
K801497 · Medical Graphics Corp. · Oct 1980
ANESTHESIA GAS MACHINE
K802116 · Puritan Bennett Corp. · Oct 1980
VITALOGRAPH FUNCTION ANALYZER
K791503 · Vitalograph , Ltd. · Aug 1979