Cleared Traditional

K954964 - AQUACENTER 2000 SYSTEM

K954964 is an FDA 510(k) clearance for AQUACENTER 2000 SYSTEM, manufactured by Aquarius Medical Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K954964 · Aquarius Medical Corp. · Orthopedic device
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Dec 1995
Decision
59d
Days
Class 2
Risk

K954964 is an FDA 510(k) clearance for the AQUACENTER 2000 SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Aquarius Medical Corp. (Irvine, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 59 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 Aquarius Medical Corp. devices

FDA 510(k) Submission Details - K954964

510(k) Number K954964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date December 28, 1995
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 122d · This submission: 59d
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 470
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K954964.
LIMITED REUSE ARTHROSCOPIC BLADES
K955914 · Smith & Nephew Dyonics, Inc. · Feb 1996
VIDEOSCOPE W/IRRIGATION SHEATH
K954016 · T. Korossurgical Instruments Corp. · Jan 1996
KARL STORZ TARGETING UNIT
K955652 · KARL STORZ Endoscopy-America, Inc. · Jan 1996
ECTRA II LIGAMENT RELEASE SYSTEM
K954627 · Smith & Nephew Dyonics, Inc. · Dec 1995
INCL ENDOSCOPE
K955471 · Sofamor Danek USA,Inc. · Dec 1995
CANNULOC THREADED CANNULA
K955273 · Linvatec Corp. · Dec 1995