Cleared Traditional

K801949 - BCM-302 COLLIMATING CONE & COMPENSATIN

K801949 is an FDA 510(k) clearance for BCM-302 COLLIMATING CONE & COMPENSATIN, manufactured by B C Medical , Ltd.. The device is a Class 1 Radiology device with product code JZW cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K801949 · B C Medical , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
49d
Days
Class 1
Risk

K801949 is an FDA 510(k) clearance for the BCM-302 COLLIMATING CONE & COMPENSATIN. Classified as Nephelometer (product code JZW), Class I - General Controls.

Submitted by B C Medical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 866.4540 - the FDA radiology and imaging software oversight 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 B C Medical , Ltd. devices

FDA 510(k) Submission Details - K801949

510(k) Number K801949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1980
Decision Date October 03, 1980
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

JZW Device Classification - Class 1, General Controls

Product Code JZW Nephelometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JZW Nephelometer

All 10
Devices cleared under the same product code (JZW) and FDA review panel - the closest regulatory comparables to K801949.
BEHRING NEPHELOMETER 100
K892223 · Behring Diagnostics, Inc. · May 1989
TURBOX
K873401 · Unipath , Ltd. · Sep 1987
RRT SYSTEM LASER REFLECTOMETER ANALYZER
K873407 · Incstar Corp. · Sep 1987
DISC 120 TRANSPORTER
K801391 · Travenol Laboratories, S.A. · Jul 1980
LANCER L-INA BUFFER, POLYMER, WASH SOLU
K792014 · Sherwood Medical Industries · Nov 1979
IMMUNOCHEMISTRY SYS. MANUAL MODE
K781006 · Beckman Instruments, Inc. · Aug 1978