Cleared Traditional

K830954 - ACOH WELLNESS TESTER

K830954 is an FDA 510(k) clearance for ACOH WELLNESS TESTER, manufactured by Bradley, Campbell & Carney. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K830954 · Bradley, Campbell & Carney · Anesthesiology device
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Jun 1983
Decision
77d
Days
Class 2
Risk

K830954 is an FDA 510(k) clearance for the ACOH WELLNESS TESTER. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Bradley, Campbell & Carney (Mchenry, US). The FDA issued a Cleared decision on June 10, 1983 after a review of 77 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.

FDA 510(k) Submission Details - K830954

510(k) Number K830954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1983
Decision Date June 10, 1983
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 60
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K830954.
AW TEST
K843848 · Erich Jaeger, Inc. · Nov 1984
APTA-BRONCHOSCREEN
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
K830954 · ACOH WELLNESS TESTER
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