Cleared Traditional

K841087 - FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000

K841087 is an FDA 510(k) clearance for FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000, manufactured by Machida America, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K841087 · Machida America, Inc. · Orthopedic device
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May 1984
Decision
64d
Days
Class 2
Risk

K841087 is an FDA 510(k) clearance for the FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Machida America, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1984 after a review of 64 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 Machida America, Inc. devices

FDA 510(k) Submission Details - K841087

510(k) Number K841087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1984
Decision Date May 16, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
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 558
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K841087.
ACUFEX ARTHROSCOPE
K843208 · Acufex Microsurgical, Inc. · Sep 1984
AMERICAN EDWARDS LABS FLEXISCOPE
K841607 · American Edwards Laboratories · Aug 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
K842323 · American Edwards Laboratories · Aug 1984
ANTHROSCOPY SYSTEM
K834146 · Cabot Medical Corp. · Mar 1984
CABOT ARTHROSCOPY SYSTEM
K833727 · Cabot Medical Corp. · Dec 1983
DISPOSABLE ARTHROSCOPY BLADE
K833587 · Dyonics, Inc. · Nov 1983