Cleared Traditional

K060458 - MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR

K060458 is an FDA 510(k) clearance for MANZI MACH 1 INSTRUMENT CLEANER-PROCESS..., manufactured by Langford IC Systems, Inc.. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K060458 · Langford IC Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
232d
Days
Class 2
Risk

K060458 is an FDA 510(k) clearance for the MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI.... Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Langford IC Systems, Inc. (East Walpole, US). The FDA issued a Cleared decision on October 12, 2006 after a review of 232 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.

FDA 510(k) Submission Details - K060458

510(k) Number K060458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2006
Decision Date October 12, 2006
Days to Decision 232 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 129d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEB Device Classification - Class 2, Special Controls

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition 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).
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 - FEB Accessories, Cleaning, For Endoscope

All 54
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K060458.
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
K063876 · Medivators Reprocessing Systems · Jun 2007
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
K061430 · Custom Ultrasonics · Jan 2007
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K061899 · Advanced Sterilization Products · Oct 2006
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K040883 · Advanced Sterilization Products · Mar 2005
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp. · Oct 2001
PSK ENDOSCOPE CLEANING SYSTEM
K000216 · Psk Connectors Pty, Ltd. · May 2000
K060458 · MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
Download PDF FDA Summary Langford IC Systems, …