Cleared Traditional

K831778 - RS-RESIDUAL VOLUME SYSTEM

K831778 is an FDA 510(k) clearance for RS-RESIDUAL VOLUME SYSTEM, manufactured by Warren E. Collins, Inc.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K831778 · Warren E. Collins, Inc. · Anesthesiology device
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Aug 1983
Decision
90d
Days
Class 2
Risk

K831778 is an FDA 510(k) clearance for the RS-RESIDUAL VOLUME SYSTEM. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Warren E. Collins, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Warren E. Collins, Inc. devices

FDA 510(k) Submission Details - K831778

510(k) Number K831778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1983
Decision Date August 31, 1983
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 44
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K831778.
AW TEST
K843848 · Erich Jaeger, Inc. · Nov 1984
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K843852 · Erich Jaeger, Inc. · Nov 1984
PNEUMOSCREEN
K843849 · Erich Jaeger, Inc. · Oct 1984
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