Cleared Traditional

K871712 - MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.

K871712 is an FDA 510(k) clearance for MACHIDA AMERICA MODEL AC-5000 AUTOMATIC..., manufactured by Machida America, Inc.. The device is a Class 2 General Hospital device with product code NVE cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K871712 · Machida America, Inc. · General Hospital
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Jan 1988
Decision
255d
Days
Class 2
Risk

K871712 is an FDA 510(k) clearance for the MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.. Classified as Washer, Cleaner, Automated, Endoscope (product code NVE), Class II - Special Controls.

Submitted by Machida America, Inc. (Orangeburg, US). The FDA issued a Cleared decision on January 14, 1988 after a review of 255 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Machida America, Inc. devices

FDA 510(k) Submission Details - K871712

510(k) Number K871712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1987
Decision Date January 14, 1988
Days to Decision 255 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 129d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NVE Device Classification - Class 2, Special Controls

Product Code NVE Washer, Cleaner, Automated, Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition This Automated Device Is Intended To Be Used To Clean Endoscopes. Endoscopes That Are Intended To Be Cleaned By The Automated Cleaner System Should Have Been Pre-cleaned And Tested For Leaks And Lumen Obstructions According To The Instrument Manufacturer's Instructions And Current Professional Practices Prior To Processing In The System. The System Includes A Chemical Dispensing System That Meters Out A Predetermined Volume Of Detergent During The Appropriate Cleaning Cycle. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). The Instrument Is Placed In A Tray With Each Lumen End Positioned In Opposite Sides Of The Tray To Allow Enough Detergent And Rinsing Water Pass Through The Lumens Of The Endoscopes.
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 General Hospital devices follow this clearance model.

Regulatory Peers - NVE Washer, Cleaner, Automated, Endoscope

All 10
Devices cleared under the same product code (NVE) and FDA review panel - the closest regulatory comparables to K871712.
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
K073112 · Intuitive Surgical, Inc. · Aug 2008
MANZI CLEANER SYSTEM
K043314 · Langford IC Systems, Inc. · Jun 2005
MODIFICATION TO SYSTEM 83 PLUS
K983017 · Custom Ultrasonics · Sep 1998
KEYMED FIBERSCOPE AUTO DISINFECTOR
K861821 · Keymed, Inc. · Feb 1987
AUTOMATIC ENDOSCOPE
K832458 · American Endoscopy, Inc. · Oct 1983