Cleared Traditional

K030910 - CLUED UP MULTIPURPOSE SOLUTION- NO RUB

K030910 is an FDA 510(k) clearance for CLUED UP MULTIPURPOSE SOLUTION- NO RUB, manufactured by Clued UP Limited. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K030910 · Clued UP Limited · Ophthalmic device
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Oct 2003
Decision
200d
Days
Class 2
Risk

K030910 is an FDA 510(k) clearance for the CLUED UP MULTIPURPOSE SOLUTION- NO RUB. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Clued UP Limited (Egham, Surrey, GB). The FDA issued a Cleared decision on October 10, 2003 after a review of 200 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Clued UP Limited devices

FDA 510(k) Submission Details - K030910

510(k) Number K030910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date October 10, 2003
Days to Decision 200 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 110d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - LPN Accessories, Soft Lens Products

All 82
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K030910.
KARATS MULTIPURPOSE SOLUTION
K031753 · Ciba Vision Corporation · Oct 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · Ciba Vision Corporation · Feb 2004
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646 · Bausch & Lomb, Inc. · Nov 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522 · Ciba Vision Corporation · Sep 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · Ciba Vision Corporation · Aug 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521 · Ciba Vision Corporation · Jun 2003