Cleared Traditional

K110900 - DISPOSABLE THYROID COLLAR

K110900 is an FDA 510(k) clearance for DISPOSABLE THYROID COLLAR, manufactured by Bloxr Corporation. The device is a Class 1 Radiology device with product code KPY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K110900 · Bloxr Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
85d
Days
Class 1
Risk

K110900 is an FDA 510(k) clearance for the DISPOSABLE THYROID COLLAR. Classified as Shield, Protective, Personnel (product code KPY), Class I - General Controls.

Submitted by Bloxr Corporation (Salt Lake City, US). The FDA issued a Cleared decision on June 24, 2011 after a review of 85 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 - K110900

510(k) Number K110900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2011
Decision Date June 24, 2011
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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 24
Devices cleared under the same product code (KPY) and FDA review panel - the closest regulatory comparables to K110900.
INTRA-ORAL THERMOPLASTIC SHIELD
K962622 · Medtec, Inc. · Oct 1996
THERMOPLASTIC SHIELD
K954456 · Medtec, Inc. · Dec 1995
UTK-DTE AUTILARY SHIELD
K954146 · Mallinckrodt Medical · Dec 1995
AUKULYTE
K953610 · Aukland Medical Plastics, Inc. · Sep 1995
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
K951004 · Kenex , Ltd. · Apr 1995
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
K951003 · Kenex , Ltd. · Apr 1995
K110900 · DISPOSABLE THYROID COLLAR
Download PDF FDA Summary Bloxr Corporation