Cleared Traditional

K951843 - REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT

K951843 is an FDA 510(k) clearance for REF. 4102CV INTERMEDIARY TUBING, manufactured by Future Medical Systems, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K951843 · Future Medical Systems, Inc. · Orthopedic device
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Jul 1995
Decision
85d
Days
Class 2
Risk

K951843 is an FDA 510(k) clearance for the REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Future Medical Systems, Inc. (New York City, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 85 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.

FDA 510(k) Submission Details - K951843

510(k) Number K951843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date July 14, 1995
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K951843.
ECTRA LIGAMENT RELEASE SYSTEM
K953387 · Smith & Nephew Dyonics, Inc. · Aug 1995
SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM
K951268 · Spine-Tech, Inc. · Jul 1995
ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
K951624 · Argus Medical Co., Inc. · Jul 1995
CITATION MULTIPLE USE DELTA SCOPE
K951941 · Citation Medical Corp. · Jul 1995
ENDO-BEND(TM) SHAVER
K950054 · Paladin Medical, Inc. · Jun 1995
CITATION DELTA SCOPE
K945390 · Citation Medical Corp. · Jun 1995
K951843 · REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
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