Cleared Traditional

K812017 - X-RAY DETECTABLE BAND

K812017 is an FDA 510(k) clearance for X-RAY DETECTABLE BAND, manufactured by Isramed, Inc.. The device is a Class 1 Radiology device with product code GDY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K812017 · Isramed, Inc. · Radiology device
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Nov 1981
Decision
126d
Days
Class 1
Risk

K812017 is an FDA 510(k) clearance for the X-RAY DETECTABLE BAND. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Isramed, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1981 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4450 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Isramed, Inc. devices

FDA 510(k) Submission Details - K812017

510(k) Number K812017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1981
Decision Date November 20, 1981
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

Product Code GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
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 - GDY Gauze/sponge, Internal, X-ray Detectable

All 58
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K812017.
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · American Medical Disposable, Inc. · Feb 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202 · American Medical Disposable, Inc. · Feb 1983
PARKE-DAVIS AEGIS ABOSRBENT SPONGES
K813595 · Deseret Medical, Inc. · Jan 1982
X-RAY DETECTABLE LAP SPONGES
K812651 · Procter & Gamble Mfg. Co. · Oct 1981
TOMAC STERILE DISP. LAP SPONGE
K812554 · American Convertors Div., American Pharmaseal · Sep 1981
GAUZE SPONGES
K803188 · Abco Dealers, Inc. · Jan 1981