Cleared Traditional

K000216 - PSK ENDOSCOPE CLEANING SYSTEM

K000216 is an FDA 510(k) clearance for PSK ENDOSCOPE CLEANING SYSTEM, manufactured by Psk Connectors Pty, Ltd.. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K000216 · Psk Connectors Pty, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
106d
Days
Class 2
Risk

K000216 is an FDA 510(k) clearance for the PSK ENDOSCOPE CLEANING SYSTEM. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Psk Connectors Pty, Ltd. (Kernersville, US). The FDA issued a Cleared decision on May 9, 2000 after a review of 106 days - within the typical 510(k) review window.

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 Psk Connectors Pty, Ltd. devices

FDA 510(k) Submission Details - K000216

510(k) Number K000216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2000
Decision Date May 09, 2000
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
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 39
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K000216.
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
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
K973558 · Ultracell Medical Technologies, Inc. · Nov 1997
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871 · Biosearch Medical Products, Inc. · Mar 1997
VIRAPUMP II (MODELS AND MODEL M)
K961607 · Viatro, Corp. · Dec 1996