Cleared Special

K010572 - BD VISIDRAPE OPHTHALMIC DRAPES (FDA 510(k) Clearance)

Also includes:
BD VISIFLEX INCISE DRAPE

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010572 · Becton, Dickinson and Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
14d
Days
Class 2
Risk

K010572 is an FDA 510(k) clearance for the BD VISIDRAPE OPHTHALMIC DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Becton, Dickinson and Co. (Sarasota, US). The FDA issued a Cleared decision on March 12, 2001 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton, Dickinson and Co. devices

Submission Details

510(k) Number K010572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date March 12, 2001
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 128d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K010572.
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · Avery Dennison Medical , Ltd. · Oct 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · 3M Company · May 2023
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · Avery Dennison Belgie Bvba · Jul 2021
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020