Cleared Traditional

K102165 - STERILE SALINE SOLUTION

K102165 is an FDA 510(k) clearance for STERILE SALINE SOLUTION, manufactured by Cachet Pharmaceuticals Pvt. , Ltd.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K102165 · Cachet Pharmaceuticals Pvt. , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
170d
Days
Class 2
Risk

K102165 is an FDA 510(k) clearance for the STERILE SALINE SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Cachet Pharmaceuticals Pvt. , Ltd. (Mumbai, IN). The FDA issued a Cleared decision on January 19, 2011 after a review of 170 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.

FDA 510(k) Submission Details - K102165

510(k) Number K102165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date January 19, 2011
Days to Decision 170 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 110d · This submission: 170d
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 114
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K102165.
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
K111877 · Bausch & Lomb, Inc. · Jan 2012
EYE-CEPT STERILE SALINE SOLUTION
K110221 · Optics Laboratory, Inc. · Nov 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · Alcon Research, Ltd. · May 2011
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
K093254 · Abbott Medical Optics, Inc. · Sep 2010
STERILE SALINE SOLUTION
K093367 · Cachet Pharmaceuticals Pvt. , Ltd. · Sep 2010
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
K102165 · STERILE SALINE SOLUTION
Download PDF FDA Summary Cachet Pharmaceutical…