Cleared Traditional

K926225 - SPONGE COUNTER

K926225 is an FDA 510(k) clearance for SPONGE COUNTER, manufactured by American Medical Manufacturer, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K926225 · American Medical Manufacturer, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1993
Decision
85d
Days
Class 1
Risk

K926225 is an FDA 510(k) clearance for the SPONGE COUNTER. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by American Medical Manufacturer, Inc. (Canoga Park, US). The FDA issued a Cleared decision on March 5, 1993 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery device 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 American Medical Manufacturer, Inc. devices

FDA 510(k) Submission Details - K926225

510(k) Number K926225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1992
Decision Date March 05, 1993
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

FWZ Device Classification - Class 1, General Controls

Product Code FWZ Operating Room Accessories Table Tray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 - FWZ Operating Room Accessories Table Tray

All 26
Devices cleared under the same product code (FWZ) and FDA review panel - the closest regulatory comparables to K926225.
RETRACTOR ARM CLAMP
K960019 · Biopsys Medical, Inc. · Feb 1996
KAPS POSITIONING ARM
K935381 · Andronic Devices, Ltd. · Apr 1994
PARK CITY SHOULDER POSITIONER
K910031 · Orthopedic Systems, Inc. · Jan 1991
SECOND ASSISTANT
K890501 · 3M Company · Feb 1989
SPINAL SURGERY FRAME
K882078 · Karlin Technology, Inc. · Jun 1988
WEHBE ARM HOLDER
K880265 · Orthopedic Systems, Inc. · Feb 1988