Cleared Traditional

K012346 - VANGUARD REPROCESSED ARTHROSCOPIC BLADES

K012346 is an FDA 510(k) clearance for VANGUARD REPROCESSED ARTHROSCOPIC BLADES, manufactured by Vanguard Medical Concepts, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K012346 · Vanguard Medical Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
84d
Days
Class 2
Risk

K012346 is an FDA 510(k) clearance for the VANGUARD REPROCESSED ARTHROSCOPIC BLADES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on October 16, 2001 after a review of 84 days - a notably fast clearance cycle.

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: 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 Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K012346

510(k) Number K012346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2001
Decision Date October 16, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

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 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K012346.
REPROCESSED ATHROSCOPICS BURS
K012605 · Alliance Medical Corp. · Nov 2001
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
K012635 · Alliance Medical Corp. · Nov 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · Sterilmed, Inc. · Nov 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
K011083 · Arthrocare Corp. · Jun 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · KARL STORZ Endoscopy-America, Inc. · Jun 2001