Cleared Traditional

K905682 - RICHARD-ALLAN CLAMP COVERS

K905682 is an FDA 510(k) clearance for RICHARD-ALLAN CLAMP COVERS, manufactured by Richard-Allan Medical. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K905682 · Richard-Allan Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
62d
Days
Class 1
Risk

K905682 is an FDA 510(k) clearance for the RICHARD-ALLAN CLAMP COVERS. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Richard-Allan Medical (Richland, US). The FDA issued a Cleared decision on February 19, 1991 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Richard-Allan Medical devices

FDA 510(k) Submission Details - K905682

510(k) Number K905682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date February 19, 1991
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - FSM Tray, Surgical, Instrument

All 39
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K905682.
OPEN HEART TRAY
K912053 · Medical Device Inspection Co., Inc. · Aug 1991
HEART CATH TRAY
K912052 · Medical Device Inspection Co., Inc. · Aug 1991
MAJOR BASIN TRAY
K912104 · Medical Device Inspection Co., Inc. · Aug 1991
HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)
K900376 · Pmt Corp. · Apr 1990
STERILE LACERATION TRAY CAT. #749
K900479 · Busse Hospital Disposables, Inc. · Feb 1990
STERILIZATION TRAY, TMJ INSTRUMENT SET
K871924 · Arthropedics, Inc. · Jun 1987