Cleared Traditional

K811068 - BYPASS COIL

K811068 is an FDA 510(k) clearance for BYPASS COIL, manufactured by G.D. Searle and Co.. The device is a Class 1 Radiology device with product code KPY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K811068 · G.D. Searle and Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1981
Decision
40d
Days
Class 1
Risk

K811068 is an FDA 510(k) clearance for the BYPASS COIL. Classified as Shield, Protective, Personnel (product code KPY), Class I - General Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - 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.

FDA 510(k) Submission Details - K811068

510(k) Number K811068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1981
Decision Date May 27, 1981
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

KPY Device Classification - Class 1, General Controls

Product Code KPY Shield, Protective, Personnel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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 - KPY Shield, Protective, Personnel

All 23
Devices cleared under the same product code (KPY) and FDA review panel - the closest regulatory comparables to K811068.
PERSONNEL PROTECTIVE SHIELD
K871502 · Cis-Us, Inc. · May 1987
VENTIBOX
K844160 · Syncor Intl. Corp. · Dec 1984
KRYPTON CART
K811677 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Jul 1981
MOTI APRON
K810095 · Moti Enterprises, Inc. · Feb 1981
FLOW MEDICAL X-RAY PROTECTIVE GLOVES
K791522 · Flow X-Ray Corp. · Oct 1979
GONAD SHIELD
K790639 · The Mochlett Laboratories, Inc. · Apr 1979
K811068 · BYPASS COIL
Download PDF G.D. Searle and Co.