Cleared Traditional

K810292 - CAM-WRAP

K810292 is an FDA 510(k) clearance for CAM-WRAP, manufactured by Medline Industries, Inc.. The device is a Class 2 Radiology device with product code FTA cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K810292 · Medline Industries, Inc. · Radiology device
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Mar 1981
Decision
29d
Days
Class 2
Risk

K810292 is an FDA 510(k) clearance for the CAM-WRAP. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Walker, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4580 - 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K810292

510(k) Number K810292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1981
Decision Date March 04, 1981
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 Radiology devices follow this clearance model.

Regulatory Peers - FTA Light, Surgical, Accessories

Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K810292.
SCB/STERIS OR-LIGHT INTERFACE BOX
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K020640 · KARL STORZ Endoscopy-America, Inc. · May 2002
DIGAPHOT PHOTOTHERAPY METER MODEL PT 145
K780162 · Cavitron Corp. · Mar 1978