Cleared Traditional

K915721 - MODEL AR-6300 INFUSION PUMP

K915721 is the FDA 510(k) clearance for MODEL AR-6300 INFUSION PUMP by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915721 · Arthrex, Inc. · Orthopedic device
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Mar 1992
Decision
90d
Days
Class 2
Risk

K915721 is an FDA 510(k) clearance for the MODEL AR-6300 INFUSION PUMP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrex, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K915721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date March 19, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K915721.
ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT
K922557 · Acufex Microsurgical, Inc. · Sep 1992
CLEARTRAC CANNULA
K920454 · Acufex Microsurgical, Inc. · Sep 1992
INTEGRATED ENDOSCOPY SYSTEM 1000
K920800 · Biomet, Inc. · Jun 1992
DANEK SPINALSCOPE
K901692 · Danek Medical, Inc. · Feb 1992
3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA
K912099 · 3M Company · Dec 1991
ARTHRO-FLOW IRRIGATION 2 SYSTEM
K913028 · Davol, Inc. · Oct 1991