Cleared Traditional

K801526 - SURVEYOR I, RESPIRATORY COMPUTER SYSTEM

K801526 is an FDA 510(k) clearance for SURVEYOR I, manufactured by The Devilbiss Co.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K801526 · The Devilbiss Co. · Anesthesiology device
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Jul 1980
Decision
19d
Days
Class 2
Risk

K801526 is an FDA 510(k) clearance for the SURVEYOR I, RESPIRATORY COMPUTER SYSTEM. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by The Devilbiss Co. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 19 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 The Devilbiss Co. devices

FDA 510(k) Submission Details - K801526

510(k) Number K801526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1980
Decision Date July 21, 1980
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
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 49
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K801526.
SPIROMETRIC COMPUTER #SC-10
K802928 · Cavitron Corp. · Dec 1980
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
ANALYZER, PULMONARY FUNCTION
K780322 · Hospal Medical Corp. · Mar 1978
PC-30 PULMONARY COMPUTER
K770532 · Cavitron Corp. · Apr 1977